Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety.
Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user fee provisions.
Makes changes to include postmarket safety activities within the process for the review of approved human drug applications or supplements, including developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems. Removes provisions limiting the postmarket safety activities to three years after approval of a new drug.
(Sec. 103) Reauthorizes prescription drug new users fees beginning in FY2008.
Requires the Secretary to provide a partial refund of an applicant's user fees if the application is withdrawn without a waiver before filing.
Sets forth special rules for compounded positron emission tomography drugs, including allowing an applicant for an approved human drug application for a compounded positron emission tomography drug to be subject to one-fifth of the annual prescription drug establishment fee.
Establishes the amount of revenue that fees are to generate for FY2008-FY2012. Sets forth provisions regarding adjustments to such fees. Requires the Secretary to: (1) contract with an independent accounting firm to study and make recommendations on the adjustment for changes in review activities; and (2) make appropriate changes to the workload adjustment methodology in setting fees for FY2010-FY2012.
Directs the Secretary to consider only the circumstances and assets of the applicant and any affiliate when determining whether to grant a waiver or reduction of fees assessed. Excludes an entity that has a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce from being considered a small business for purposes of application fee waiver rules.
(Sec. 104) Requires the Secretary to assess and collect fees for advisory review by the Secretary of direct-to-consumer television advertisement for a prescription drug product. Sets forth procedures for such review.
Subjects each person that is assessed an advisory review fee to an operating reserve fee for the first fiscal year in which an advisory review fee is assessed. Establishes the amount of revenue that may be generated from such fees.
Requires the Secretary to annually set the fee for advisory review based on the number of direct-to-consumer advertisements that the Secretary will review in the next fiscal year. Sets forth fee limits.
Requires the Secretary to establish a Direct-to-Consumer Advisory Review Operating Reserve in the Food and Drug Administration (FDA) salaries and expenses appropriation account to continue such review in the event the fees collected in any subsequent fiscal year do not generate the fee revenue amount established for that fiscal year.
Terminates such advisory review if the Secretary fails to receive a certain amount of advisory review fees and operating reserve fees.
Terminates provisions for prescription drug user fees on October 1, 2012, except certain reporting requirements.
Title II: Drug Safety - (Sec. 200) Enhancing Drug Safety and Innovation Act of 2007- Subtitle A: Risk Evaluation and Mitigation Strategies - (Sec. 201) Amends the FFDCA to require the Secretary to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.
Directs the Secretary to: (1) establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis, including procedures to provide for adverse event surveillance by collecting and monitoring health-related electronic data; and (2) develop, support, and participate in complementary approaches to gather and analyze such data and information to the extent the active surveillance infrastructure is not sufficient to gather data and information relevant to priority drug safety questions.
Requires the Secretary to establish collaborations with other government, academic, and private entities to provide for the risk identification and analysis of collected data and data that is publicly available or is provided to the Secretary in order to: (1) improve the quality and efficiency of postmarket drug safety risk-benefit analysis; (2) provide the Secretary with routine access to expertise to study advanced drug safety data; and (3) enhance the ability of the Secretary to make timely assessments based on drug safety data.
Directs the Secretary to seek recommendations from the Drug Safety and Risk Management Advisory Committee at least biannually on: (1) priority drug safety questions; and (2) mechanisms for answering such questions.
Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data; (2) allow for prompt investigation of priority drug safety questions; (3) perform advanced research and analysis on identified drug safety risks; (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for postmarketing data collected; and (5) focus postmarket studies and post-approval clinical trials on cases for which reports and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a drug.
Authorizes appropriations for FY2008-FY2012.
(Sec. 202) Requires a proposed risk evaluation and mitigation strategy for a new drug to include: (1) labeling for the drug for use by health care providers; and (2) a timetable for submission of assessments of the strategy. Sets forth as additional elements that a risk evaluation and mitigation strategy may include: (1) post-approval studies; (2) advertisement pre-review requirements; (3) specific disclosures in advertisements; and (4) additional elements to assure safe use. Allows an application for approval of a new drug or a license for a biological product to include a proposed risk evaluation and mitigation strategy if there is a signal of a serious risk with a drug. Authorizes the Secretary to require that the applicant submit a proposed risk evaluation and mitigation strategy if the Secretary determines that, based on such a signal, a risk evaluation and mitigation strategy is necessary to assess such signal or mitigate such risk. Sets forth a time frame for submission of such a strategy when ordered by the Secretary. Allows (or requires, if ordered by the Secretary) an applicant to submit assessments or propose modifications of such a strategy.
Establishes a Drug Safety Oversight Board to: (1) oversee disputes related to a proposed risk evaluation and mitigation strategy, except for disputes during initial approval of a drug; and (2) provide oversight and advice to the Secretary on the management of important drug safety issues.
Sets forth civil penalties for knowingly failing in an application to comply with a requirement of an approved risk evaluation and mitigation strategy.
(Sec. 203) Deems a drug to be misbranded if it is a drug subject to an approved risk evaluation and mitigation strategy and the applicant fails to: (1) make a labeling change required by such strategy; or (2) comply with the advertising requirements of such strategy. Sets forth civil penalties for knowingly failing to comply with a requirement of such strategy.
(Sec. 204) Amends the Public Health Service Act to allow an applicant for a license for a biological product to submit to the Secretary a proposed risk evaluation and mitigation strategy.
(Sec. 205) Authorizes the Secretary to withdraw or suspend approval of a new drug application without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug.
(Sec. 206) Provides that a drug that is the subject of an abbreviated new drug application (generic) shall be subject to only the following elements of an approved risk evaluation and mitigation strategy if required for the applicable listed drug: (1) labeling, as required for the applicable listed drug; (2) a Medication Guide or patient package insert; (3) pre-review of advertising; (4) specific disclosures in advertising; and (5) elements to assure safe use as necessary.
(Sec. 207) Includes within the process for review of human drug application requirements that the Secretary conduct postmarket safety activities that include reviewing, implementing, and ensuring compliance with risk evaluation and mitigation strategies.
Sets forth fee revenue amounts for FY2008-FY2012.
Requires the Secretary to submit to the relevant congressional committees a strategic plan on information technology that includes: (1) an assessment of the information technology infrastructure; (2) an assessment of the extent to which the current FDA information technology assets are sufficient to meet needs; and (3) a plan and assessment of resources needed for enhancing such assets.
(Sec. 208) Requires the holder of an approved new drug application or a biological product license to promptly notify the Secretary of new safety information that should be included in the labeling of the drug. Requires the Secretary to promptly notify the holder if the Secretary becomes aware of new safety information that should be included. Sets forth an accelerated labeling review process to resolve disagreements between the Secretary and a holder about the need for, or content of, safety labeling changes. Requires the Drug Safety Oversight Board to resolve such disputes, as necessary.
(Sec. 209) Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to such data by developing and maintaining an Internet website that: (1) provides comprehensive drug safety information for approved prescription drugs; and (2) improves communication of drug safety information to patients and providers.
Requires the Advisory Committee on Risk Communication to: (1) regularly perform a comprehensive review and evaluation of the types of risk communication information provided on such website; and (2) recommend ways for the FDA to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers.
(Sec. 210) Requires that certain information related to a new drug application be published on the FDA's website, including: (1) documents generated by the FDA related to review of an application; and (2) a summary review of conclusions from all reviewing disciplines about the drug. Provides that a scientific review of an application is considered the work of the reviewer. Prohibits the altering of such work by management or the reviewer once it is final.
(Sec. 211) Requires the Secretary to establish the Advisory Committee on Risk Communication to advise the Commissioner on which methods to use to effectively communicate risk associated with the products regulated by the FDA.
Requires the Secretary to partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.
(Sec. 212) Requires the Secretary to refer a drug of which no active ingredient has been approved in any other application to an FDA advisory committee for review prior to approval. Allows the advisory committee review to occur within one year after approval if: (1) the clinical trial that formed the primary basis of the safety and efficacy determination was halted by a drug safety monitoring board of an Institutional Review Board before its scheduled completion due to early unanticipated therapeutic results; or (2) the Secretary determines that it would be beneficial to the public health.
(Sec. 213) Requires the Secretary to issue a report responding to the Institute of Medicine report on drug safety.
(Sec. 214) Deems drugs approved before the effective date of this Act to have an approved risk evaluation and mitigation strategy if there are restrictions on distribution or use of such a drug. Requires the Secretary to notify applicants of the date by which an assessment of an approved strategy must be submitted, which date shall be no earlier than six months after the applicant is notified, except with respect to the drug Mifeprex (mifepristone) for which such assessment must be submitted six months after the applicant is notified.
Subtitle B: Reagan-Udall Foundation for the Food and Drug Administration - (Sec. 221) Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Requires the Foundation to: (1) identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness of devices, biologics, and drugs and the safety of food, food ingredients, and cosmetics; (2) establish goals and priorities; (3) identify federal research and development programs and minimize duplication; (4) award grants to scientists and entities to efficiently and effectively advance such goals and priorities; and (5) provide objective clinical and scientific information to the FDA and other federal agencies. Requires the Foundation's Board of Directors to appoint an Executive Director. Directs the Commissioner to receive and assess reports submitted by the Executive Director. Sets forth reporting requirements.
(Sec. 222) Requires the Secretary to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office and ensure that there is no duplication of research efforts supported by the Foundation; (3) develop and advocate for a budget to support intramural research; (4) develop a peer review process by which intramural research can be evaluated; and (5) identify and solicit intramural research proposals from across the FDA through an advisory board composed of FDA employees.
Subtitle C: Clinical Trials - (Sec. 231) Amends the Public Health Service Act to require the Secretary, acting through the Director of NIH, to expand the clinical trials registry data bank. Requires the Director to ensure that the data bank is made publicly available through the Internet. Requires the Secretary to expand the data bank to require the submission of specified information for applicable drug clinical trials and applicable device clinical trials. Requires the Secretary to ensure that the data bank includes links to results information for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved or device involved is cleared or approved.
Requires the Director to conduct a study to determine the best, validated methods of making the results of clinical trials publicly available after the approval of drugs.
Prohibits the submission of promotional or false or misleading clinical trial information. Sets forth civil penalties for violations.
Subtitle D: Conflicts of Interest - (Sec. 241) Requires the Secretary to recruit individuals to serve as advisory committee members. Requires the Secretary to review the individual's financial disclosure report and expertise when considering a term appointment to an advisory committee. Sets forth provisions governing the granting of waivers and financial interests of advisory committee members.
Subtitle E: Other Drug Safety Provisions - (Sec. 251) Directs the Commissioner to publish and update, quarterly, a complete list of all authorized generic drugs on the FDA's website.
(Sec. 252) Requires the Secretary to require that state-legalized medical marijuana be subject to the full regulatory requirements of the FDA.
Subtitle F: Antibiotic Access and Innovation - (Sec. 261) Makes certain antibiotic drugs eligible for market exclusivity if an application for marketing is submitted after enactment of this Act for an antibiotic drug that: (1) was approved by the Secretary before November 21, 1997; or (2) was the subject of one or more applications received by the Secretary before November 21, 1997, none of which was approved.
(Sec. 262) Requires the Commissioner of Food and Drugs to convene a public meeting regarding which serious and life-threatening infectious diseases potentially qualify for available grants and contracts or other incentives for orphan drug development.
(Sec. 263) Requires the Secretary, through the Commissioner, to identify and periodically update clinically susceptible concentrations (specific values that characterize bacteria as clinically susceptible, intermediate, or resistant to the drug tested).
(Sec. 264) Allows an applicant for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application to elect to have the single enantiomer considered the same active ingredient as that contained in the approved racemic drug under certain circumstances.
(Sec. 265) Direct the Comptroller General to submit a report to the relevant congressional committees that examines whether and how this subtitle has: (1) encouraged the development of new antibiotics and other drugs; and (2) prevented or delayed timely generic entry into the market.Title III: Medical Devices - Subtitle A: Device User Fees - (Sec. 301) Medical Device User Fee Amendments of 2007 - (Sec. 302) Establishes the purpose of collecting medical device fees, including that such fees be dedicated towards expediting the process for the review of device applications and assuring the safety and effectiveness of devices.
Sets forth reporting requirements, including requiring the Secretary to report to the relevant congressional committees on the FDA's progress in achieving specified goals.
Terminates medical device user fee provisions on October 1, 2012, except certain reporting requirements.
(Sec. 303) Makes changes to medical device fees, including establishing fees for: (1) a 30-day notice for a supplement to an approved premarket application or premarket report that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and effectiveness of the device; (2) a request for classification information; (3) periodic reporting concerning a class III device; and (4) each initial or annual registration for establishments subject to a registration fee.
Establishes medical device fee amounts.
Makes changes to provisions related to qualifications for fee waivers for small businesses.
Authorizes appropriations.
(Sec. 305) Makes this subtitle effective on October 1, 2007.
Subtitle B: Amendments Regarding Regulation of Medical Devices - (Sec. 311) Requires a person accredited to conduct inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices to notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems for any device establishment that such person inspects within 30 days after such action. Allows an accredited person to conduct audits to establish conformance with the quality systems. Sets forth conditions that a device establishment must meet to be eligible for inspections by accredited persons. Deems a device establishment to have clearance to participate in the program and to use an accredited person for inspections unless the Secretary denies such clearance or requests certain compliance data or information concerning the relationship between the owner of the establishment and the accredited person. Sets forth conditions under which the Secretary may deny clearance.
(Sec. 312) Extends the authority of accredited persons to review pre-market reports for devices and make recommendations to the Secretary regarding the initial classification of devices.
(Sec. 313) Requires every person who owns or operates any establishment in any state engaged in the manufacture, preparation, propagation, compounding, or processing of a device to register with the Secretary. Requires any such establishment within a foreign country to register electronically with the Secretary.
(Sec. 314) Requires a registered person to report to the Secretary with regard to devices once each year.
(Sec. 315) Requires electronic registration for device establishments, unless the Secretary grants a waiver.
Title IV: Pediatric Medical Products - Subtitle A: Best Pharmaceuticals for Children - Best Pharmaceuticals for Children Amendments of 2007 - (Sec. 402) Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that the studies are completed using appropriate formulations for each age group for which the study is requested; (2) require that appropriate labeling changes are made as determined appropriate by the Secretary within a time frame requested by the Secretary; and (3) prohibit the Secretary from extending market exclusivity if the determination of eligibility for such market exclusivity is made less than nine months prior to its expiration.
Requires an applicant or holder who does not agree with a request to conduct pediatric studies on the grounds that it is not possible to develop the appropriate pediatric formulation to submit to the Secretary the reasons such pediatric formulation cannot be developed. Requires an applicant or holder that agrees to such a request to provide the Secretary with all postmarket adverse event reports regarding the drug that are available prior to submission of reports on such studies.
Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if the formulation is not introduced onto the market within one year after the Secretary's determination regarding market exclusivity; and (2) create an internal review committee to review all written requests issued and all reports submitted. Requires the committee to be responsible for tracking and making available to the public: (1) the number of pediatric studies conducted; (2) the specific drugs and uses studied; (3) the types of studies conducted, the number of pediatric patients studied, and the number of centers and countries involved; (4) the number of pediatric formulations developed and the number not developed and the reasons formulations were not developed; (5) the labeling changes made as a result of studies; (6) an annual summary of labeling changes made as a result of studies conducted for distribution; and (7) information regarding reports submitted after enactment of this Act.
Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.
Requires the Secretary to: (1) order the labeling of a drug to include information about the result of a pediatric study whether it does or does not demonstrate that the drug is safe and effective, including whether such study results are inconclusive; (2) ensure that all adverse event reports that have been received are referred to the Office of Pediatric Therapeutics for review.
(Sec. 403) Reauthorizes the Secretary, acting through the Director of NIH, to: (1) develop, publish, and revise every three years a priority list of needs in pediatric therapeutics; and (2) report to Congress on the feasibility of establishing a compilation of information on pediatric drug use. Requires the Director to submit proposed pediatric study requests for consideration by the Commissioner.
(Sec. 404) Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.
Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the written requests made for pediatric studies and the studies conducted.
(Sec. 405) Requires the Director of the National Institute of Child Health and Human Development to include health professionals who intend to build careers in pediatric pharmacological research within the Institute's career development activities.
Includes pediatric pharmacological research within the pediatric research loan repayment program.
(Sec. 406) Authorizes the Foundation for the National Institutes of Health to solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of pediatric studies of drugs for which the Secretary determines that there is a continuing need for information relating to the use of the drug in a pediatric population.
(Sec, 407) Requires the advisory committee on pediatric therapeutics to continue to operate for five years after enactment of this Act.
(Sec. 408) Requires the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to: (1) provide recommendations to the internal review committee that reviews pediatric research requests with respect to the treatment of pediatric cancer; and (2) continue to operate for five years after enactment of this Act. Sets forth reporting requirements.
(Sec. 409) Directs that the proposed rule issued by the Commissioner entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" take effect on January 1, 2008, unless the the final rule is issued before such date.
Subtitle B: Pediatric Research Improvement - Pediatric Research Improvement Act - (Sec. 412) Requires an applicant seeking a waiver from requirements to submit pediatric assessments for new drugs and biological products to submit to the Secretary documentation detailing why a pediatric formulation cannot be developed.
Requires an applicant to annually submit to the Secretary: (1) information detailing the progress made in conducting pediatric studies; or (2) if no progress has been made, evidence and documentation that such studies will be conducted with due diligence and at the earliest possible time. Requires such information to promptly be made publicly available.
(Sec. 413) Requires an applicant seeking a waiver from a requirement to submit a pediatric assessment for an already marketed drug or biological product to submit to the Secretary documentation detailing why a pediatric formula cannot be developed. Requires the the applicant's submission to promptly be made available to the public if such a waiver is granted.
(Sec. 414) Requires the Secretary to create an internal committee to review pediatric assessment requests, pediatric assessments conducted, and deferral and waiver requests from such requirements. Makes the committee responsible for tracking and making public in an easily accessible manner information related to such pediatric assessments, including: (1) the number of assessments conducted and the drugs and drug uses assessed; (2) the number of pediatric formulations developed and the number not developed and the reasons formulations were not developed; and (3) the labeling changes made as a result of assessments.
Deems any supplement to a new drug applicant or license for a biological product proposing a labeling change as a result of any pediatric assessments to be a priority supplement.
Provides for referral to the Pediatric Advisory Committee for disputes on labeling changes. Requires the Secretary to: (1) order the labeling of a product to include information about the results of the assessment and a statement of the Secretary's determination that a pediatric assessment does or does not demonstrate that the drug is safe and effective; and (2) make publicly available the medical, statistical, and clinical pharmacology reviews of such pediatric assessments; and (3) ensure that all adverse event reports that have been received for the drug are referred to the Office of Pediatric Therapeutics for review.
(Sec 415) Considers a drug to represent a meaningful therapeutic benefit over existing therapies if the Secretary determines (currently, estimates) that the drug or biological product if approved could (currently, would) represent a significant improvement in the treatment, diagnosis, or prevention of a disease.
(Sec. 416) Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies of new drugs or biological products conducted pursuant to the FFDCA since 1997.
Requires the Comptroller General to submit to Congress a report that addresses the effectiveness of such studies in ensuring that medicines used by children are tested and properly labeled.
Subtitle C: Pediatric Medical Devices - Pediatric Medical Device Safety and Improvement Act of 2007 - (Sec. 422) Requires applications for a humanitarian device exemption, an application for premarket approval of a medical device, or a product development protocol for a medical device to include, if readily available: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure and (2) the number of affected pediatric patients.
Requires the Secretary to submit to the relevant congressional committees an annual report that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved; and (4) the review time for each approved device.
Authorizes the Secretary to conclude that adult data on medical devices may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations if the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients.
(Sec. 423) Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device, if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; (2) the device was not approved for pediatric patients prior to enactment of this Act; (3) the number of devices distributed does not exceed an annual distribution number specified by the Secretary; and (4) the request for exemption is submitted on or before October 1, 2012.
Requires the Secretary to refer any adverse event report related to a device to the Office of Pediatric Therapeutics for review.
Directs the Comptroller General to report on the impact of allowing persons granted a humanitarian device exemption to profit from such device.
(Sec. 424) Requires the Secretary, acting through the Director of NIH, to designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.
(Sec. 425) Requires the Secretary to award grants for demonstration projects to promote pediatric device development.
(Sec. 426) Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Requires the Office to report to the relevant congressional committees a plan for expanding pediatric medical device research and development. Expands the duties of the advisory committee on pediatric therapeutics to include providing advice and recommendations on matters relating to medical devices.
(Sec. 427) Allows the Secretary to require: (1) postmarket surveillance on class II or class III medical devices that are expected to have significant use in pediatric populations; (2) a postmarket surveillance as a condition of approval of an application or a product development protocol or as a condition to clearance of a premarket notification for such pediatric devices; and (3) a prospective surveillance period of more than 36 months for such pediatric devices as necessary to assess the impact of the device on growth and development or the effects of growth, development, activity level, or other factors on the safety of the device.
Title V: Other Provisions - (Sec. 501) Amends the FFDCA to require the Secretary, through the Commissioner of Food and Drugs, to establish and make publicly available clear written policies to govern the timely submission, review, clearance, and disclaimer requirements for publication of articles by an FDA officer or employee.
(Sec. 504) Expresses the sense of the Senate that legislation should be enacted to provide the FDA with the authority and flexibility to approve biopharmaceuticals subject to an abbreviated approval pathway.
(Sec. 505) Requires the Secretary to: (1) award a transferable, priority review voucher to the sponsor of a tropical disease product upon approval by the Secretary of such product; and (2) establish a priority review user fee program.
(Sec. 506) Prohibits the Secretary from delaying approval of a new drug application while a petition is reviewed or considered, unless such a delay is necessary to protect the public health. Requires the Secretary to take final agency action on a petition not later than 180 days after submission, unless such a delay is necessary. Requires petitions to be signed and to contain specified verifications.
Sets forth reporting requirements.
Requires the Office of the Inspector General of the Department of Health and Human Services (HHS) to evaluate evidence of FDA compliance with the requirement that the consideration by the Secretary of petitions that do not raise public health concerns remain separate and apart from the review and approval of a new drug application.
(Sec. 507) Requires the Commissioner to annually submit to Congress and the public on the FDA's Internet website a report concerning the results of the FDA's pesticide residue monitoring program.
(Sec. 508) Amends the Head Start Act to require a Head Start agency to obtain written parental consent before administration of any nonemergency intrusive physical examination of a child in connection with participation in a Head Start program.
(Sec. 509) Requires the FDA to report on the question of whether substances used to preserve the appearance of fresh meat may create any health risks or mislead consumers.
(Sec. 510) Requires the Secretary to enter into a contract with the Institute of Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve federal oversight and regulation of genetic tests.
(Sec. 511) Expresses the sense of the Senate that the FDA should enter into a contract with the Institute of Medicine for a study concerning measures that may be taken to improve the likelihood that FDA-approved drugs that are safe and effective in treating children with orphan diseases (rare genetic diseases) are made available and affordable for pediatric indications.
(Sec. 512) Requires the Secretary, after the close of a fiscal year in which color certification fees are collected, to submit to Congress: (1) a performance report on the number of batches of color additives approved, the average turn around time for approval, and quantifiable goals for improving laboratory efficiencies; and (2) a financial report for the color certification program.
(Sec. 513) Prohibits any food product from being imported into the United States that is the product of a registered foreign food facility that refuses to permit U.S. inspectors, upon request, to inspect such facility or that unduly delays access to U.S. inspectors.
(Sec. 514) Provides that the certification requirement before implementation of the prescription drug importation provisions under this Act shall not apply to requirements for counterfeit-resistant technologies.
(Sec. 515) Authorizes the Secretary to enhance, as necessary, the inspection regime of the FDA for aquaculture and seafood, consistent with U.S. obligations under international agreements and U.S. law.
(Sec. 516) Expresses the sense of the Senate that the U.S. Trade Representative should: (1) use all available tools to address violations and other concerns with intellectual property; and (2) develop and submit to Congress a strategic plan to address the problem of countries infringing upon American pharmaceutical intellectual property rights and engaging in price manipulation.
(Sec. 517) Requires the Commissioner of Food and Drugs to produce a report on any environmental risks associated with genetically engineered seafood products.
(Sec. 518) Requires the Secretary to submit to the relevant congressional committees a report on the differences between taxonomies of certain species of lobster.
(Sec. 519) Establishes civil penalties for dissemination of false or misleading direct-to-consumer advertisements for a prescription drug.
(Sec. 520) Requires the Secretary, acting through the Commissioner, to determine whether: (1) the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks of irreversible damage to the eyes and skin, including skin cancer; (2) modifying the warning label required on tanning beds would communicate such risks more effectively; and (3) there is no warning that would be capable of adequately communicating such risks. Requires the Secretary, in making such determinations, to: (1) conduct appropriate consumer testing using the best available methods for determining consumer understanding of label warnings; and (2) hold public hearings and solicit comments from the public.
Title VI: Food Safety - (Sec. 602) Requires the Secretary to establish: (1) processing and ingredient standards with respect to pet food, animal waste, and ingredient definitions; and (2) update standards pet food labeling that includes nutritional and ingredient information.
Requires the Secretary to establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.
(Sec. 603) Requires the Secretary, during an ongoing recall of human or pet food, to: (1) work with companies, professional associations, and other organizations to collect and aggregate pertinent information; (2) use existing networks of communication to enhance the quality and speed of communication with the public; and (3) post information regarding recalled products on the FDA's website in a consolidated, searchable form that is easily accessed and understood by the public.
(Sec. 604) Requires the Secretary to work with states in undertaking activities that assist in improving the safety of fresh and processed produce.
(Sec. 605) Requires the Secretary to establish an Adulterated Food Registry to which instances of reportable adulterated food may be submitted by the FDA. Requires the Secretary to issue an alert if the Registry shows that a food: (1) has been associated with repeated and separate outbreaks of illness or has been repeatedly determined to be adulterated; or (2) is a reportable adulterated food. Allows such an alert to apply to a particular food or to food from a particular producer, manufacturer, shipper, growing area, or country.
Requires a responsible party or importer who determines that an article of food it produced, processed, manufactured, distributed, or otherwise handled is a reportable adulterated food to provide notification to other parties linked in the supply chain and to submit a report to the FDA.
Requires the Secretary to immediately notify the Secretary of Homeland Security if the Secretary suspects such food may have been deliberately adulterated.
(Sec. 606) Expresses the sense of the Senate that: (1) it is vital for Congress to provide the FDA with additional resources, authorities, and direction to ensure the safety of the U.S. food supply; (2) the Secretary should make it a priority to enter into agreements with U.S. trading partners with respect to food safety; and (3) the Senate should work to develop a comprehensive response to the issue of food safety.
(Sec. 607) Sets forth reporting requirements with respect to food products regulated by the FDA.
(Sec. 609) Authorizes appropriations.
Title VII: Domestic Pet Turtle Market Access - Domestic Pet Turtle Market Access Act of 2007 - (Sec. 703) Prohibits the Food and Drug Administration (FDA) from restricting the sale by a turtle farmer, wholesaler, or other commercial retail seller of a turtle that is less than 10.2 centimeters in diameter as a pet if: (1) the state or territory in which such farmer is located has developed a regulatory process by which pet turtle farmers are required to have a state license; (2) such state or territory requires certification of sanitization that requires each turtle to be sanitized or treated for diseases and is dependent upon using proven non-antibiotic methods to make the turtle salmonella-free; and (3) the turtle farmer or commercial retail seller makes certain disclosures to a buyer. Sets forth required disclosures, which include: (1) information regarding the possibility that salmonella can re-colonize in turtles, the dangers that could result if the turtle is not properly handled and safely maintained, the proper handling of the turtle, and the proven methods of treatment that keep the turtle safe from salmonella; (2) a detailed explanation of how to properly treat the turtle to keep it safe from salmonella and how the buyer can continue to purchase the tools, treatments, or any other required item to continually treat the turtle; and (3) a statement that buyers of pet turtles should not abandon turtles, but should instead return them to a commercial retail pet seller or other organization that would accept turtles no longer wanted as pets.
(Sec. 704) Authorizes the Commissioner of Food and Drugs to restrict the sale of a turtle only if the Secretary determines that the actual implementation of state health protections are insufficient to protect consumers against infectious diseases acquired from such turtle at the time of sale.
Title VIII: Importation of Prescription Drugs - Pharmaceutical Market Access and Drug Safety Act of 2007 - (Sec. 804) Amends the FFDCA to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States.
Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Defines "qualifying drug" as a drug for which there is a corresponding U.S. label drug.
Includes among registration conditions for importers and exporters: (1) the drug to be imported or exported was manufactured in an approved facility and manufactured for sale in the United States or a permitted country; (2) a chain of custody exists for such drug; (3) the exporter or importer allows onsite inspections by the Secretary; (4) there is proper labeling of the shipment; (5) importers provide prior notice of all shipments; and (6) importers and exporters pay a registration fee and an inspection fee.
Requires the Secretary to inspect places of business, verify chain of custody, review records, monitor shipment labels, inspect facilities, and check for compliance with registration conditions.
Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences, labeling requirements, and bioequivalence.
Establishes conditions for individual importation of a qualifying drug, including requiring a valid prescription and a quantity not exceeding a 90-day supply.
Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person engaged in the importation of a qualifying drug. Allows states to bring actions for violations.
States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.
Gives priority in the registration of exporters to significant Canadian exporters. Allows the Secretary to limit the number of registered exporters and importers.
Requires the Secretary to educate consumers regarding prescription drug importation.
(Sec. 805) Requires the Secretary of Homeland Security to deliver violative shipments to the Secretary. Requires the Secretary to destroy such shipments under certain circumstances.
(Sec. 806) Requires the Secretary to establish alternative requirements to identify the chain of custody of a drug from the manufacturer throughout the wholesale distribution to a pharmacist who intends to sell the drug at retail if the Secretary determines that such requirements: (1) will identify such chain of custody or the identity of the discrete package from which the drug is dispensed with equal or greater certainty than current requirements; and (2) are economically and technically feasible.
Directs the Secretary to require the use of standardized anti-counterfeiting and track-and-track technologies on prescription drugs at the case and pallet level. Sets forth additional counterfeiting technologies to be incorporated into prescription drug packaging.
(Sec. 807) Prohibits any person from dispensing a prescription drug pursuant to a sale if: (1) any part of the sales transaction for the drug is conducted through an Internet site; (2) the person dispenses the drug to the purchaser by mailing or shipping the drug to the purchaser; and (3) such site fails to meet specified requirements regarding inclusion of a page (and links thereto) providing the identities and licensing information of the seller, pharmacists, or medical consultants.
Prohibits a person from selling or dispensing a prescription drug if: (1) the purchaser communicated with the person through the Internet; (2) the purchaser did not have a valid prescription when the communication began; (3) the person provided for the involvement of a practitioner; (4) the practitioner issued a prescription for the drug that was purchased; (5) the person knew that no qualifying medical relationship existed (defines "qualifying medical relationship" as requiring an in-person medical evaluation); and (6) the person received payment.
Allows states to bring civil actions against a person for violations of this Act.
Prevents Internet providers from being held liable for dispensing or selling prescription drugs on account of another person's activities.
Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under the FFDCA.
Requires the Secretary to award a grant or contract to the National Clearinghouse on Internet Prescribing to identify and report Internet sites that violate federal or state laws concerning the dispensing of drugs.
(Sec. 808) Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.
Requires the Board of Governors of the Federal Reserve System to promulgate regulations requiring designated payment systems to establish policies and procedures that are reasonably designed to prevent the introduction of a restricted transaction into a payment system.
(Sec. 809) Amends the Controlled Substances Import and Export Act to allow a U.S. resident entering the United States with a controlled substance for which the individual does not have a valid prescription to import not more than ten dosage units combined of all such controlled substances.
(Sec. 811) Directs that this title only becomes effective if the Secretary certifies to Congress that its implementation will: (1) pose no additional risk to the public's health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer.
[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1082 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 1082
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and
amend the prescription drug user fee provisions, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 10, 2007
Mr. Kennedy introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and
amend the prescription drug user fee provisions, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCES IN ACT.
(a) Short Title.--This Act may be cited as the ``Prescription Drug
User Fee Amendments of 2007''.
(b) References in Act.--Except as otherwise specified, whenever in
this Act an amendment is expressed in terms of an amendment to a
section or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 2. DRUG FEES.
Section 735 (21 U.S.C. 379g) is amended--
(1) by striking the section designation and all that
follows through ``For purposes of this subchapter:'' and
inserting the following:
``SEC. 735. DRUG FEES.
``(a) Purpose.--It is the purpose of this part that the fees
authorized under this part be dedicated toward expediting the drug
development process, the process for the review of human drug
applications, and postmarket drug safety, as set forth in the goals
identified for purposes of this subchapter in the letters from the
Secretary to the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee on Energy
and Commerce of the House of Representatives, as set forth in the
Congressional Record.
``(b) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
subsection (a) during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals. The
report for a fiscal year shall include information on all
previous cohorts for which the Secretary has not given a
complete response on all human drug applications and
supplements in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to the
public on the Internet website of the Food and Drug
Administration.
``(c) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of human drug
applications for the first 5 fiscal years after fiscal year
2012, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
``(D) hold a meeting at which the public may
present its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress the
revised recommendations under paragraph (2), a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(d) Definitions.--For purposes of this part:'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking
``505(b)(1),'' and inserting ``505(b), or'';
(ii) by striking subparagraph (B);
(iii) by redesignating subparagraph (C) as
subparagraph (B); and
(iv) in the matter following subparagraph
(B), as so redesignated, by striking
``subparagraph (C)'' and inserting
``subparagraph (B)'';
(B) in paragraph (3)(C), by--
(i) striking ``the list'' and inserting
``the list (not including the discontinued
section of such list)''; and
(ii) striking ``a list'' and inserting ``a
list (not including the discontinued section of
such a list)'';
(C) in paragraph (4), by inserting before the
period at the end the following: ``(such as capsules,
tablets, and lyophilized products before
reconstitution)'';
(D) by amending paragraph (6)(F) to read as
follows:
``(F) In the case of drugs approved under human
drug applications or supplements, postmarket safety
activities, including--
``(i) collecting, developing, and reviewing
safety information on approved drugs (including
adverse event reports);
``(ii) developing and using improved
adverse event data collection systems
(including information technology systems); and
``(iii) developing and using improved
analytical tools to assess potential safety
problems (including by accessing external data
bases).'';
(E) in paragraph (8)--
(i) by striking ``April of the preceding
fiscal year'' and inserting ``October of the
preceding fiscal year''; and
(ii) by striking ``April 1997'' and
inserting ``October 1996'';
(F) by redesignating paragraph (9) as paragraph
(10); and
(G) by inserting after paragraph (8) the following:
``(9) The term `person' includes an affiliate thereof.''.
SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``2003'' and inserting ``2008'';
(2) in paragraph (1)--
(A) in subparagraph (D)--
(i) in the heading, by inserting ``or
withdrawn before filing'' after ``refund of fee
if application refused for filing''; and
(ii) by inserting before the period at the
end the following: ``or withdrawn without a
waiver before filing'';
(B) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(C) by inserting after subparagraph (D) the
following:
``(E) Fee for application previously refused for
filing or withdrawn before filing.--An application or
supplement that has been refused for filing or that was
withdrawn before filing, if filed under protest or
resubmitted, shall be subject to the fee under
subparagraph (A) (unless an exception under
subparagraph (C) or (F) applies or the fee is waived or
reduced under subsection (d)), without regard to
previous payment of such a fee and the refund of 75
percent of that fee under subparagraph (D).''; and
(3) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraph
(B)'' and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following:
``(C) Special rules for compounded positron
emission tomography drugs.--
``(i) In general.--Except as provided in
clause (ii), each person who is named as the
applicant in an approved human drug application
for a compounded positron emission tomography
drug shall be subject under subparagraph (A) to
one-quarter of an annual establishment fee with
respect to each such establishment identified
in the application as producing compounded
positron emission tomography drugs under the
approved application.
``(ii) Exception from annual establishment
fee.--Each person who is named as the applicant
in an application described in clause (i) shall
not be assessed an annual establishment fee for
a fiscal year if the person certifies to the
Secretary, at a time specified by the Secretary
and using procedures specified by the
Secretary, that--
``(I) the person is a not-for-
profit medical center that has only 1
establishment for the production of
compounded positron emission tomography
drugs; and
``(II) at least 95 percent of the
total number of doses of each
compounded positron emission tomography
drug produced by such establishment
during such fiscal year will be used
within the medical center.''.
(b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is
amended to read as follows:
``(b) Fee Revenue Amounts.--Except as provided in subsections (c),
(d), (f), and (g), fees under subsection (a) shall be established to
generate the following revenue amounts, in each fiscal year beginning
with fiscal year 2008 and continuing through fiscal year 2012:
$392,783,000, plus an adjustment for workload on $354,893,000 of this
amount. Such adjustment shall be made in accordance with the workload
adjustment provisions in effect for fiscal year 2007, except that
instead of commercial investigational new drug applications submitted
to the Secretary, all commercial investigational new drug applications
with a submission during the previous 12-month period shall be used in
the determination. One-third of the revenue amount shall be derived
from application fees, one-third from establishment fees, and one-third
from product fees.''.
(c) Adjustments to Fees.--
(1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C.
379h(c)(1)) is amended--
(A) in the matter preceding subparagraph (A) by
striking ``The revenues established in subsection (b)''
and inserting ``Beginning with fiscal year 2009, the
revenues established in subsection (b)'';
(B) in subparagraph (A) by striking ``or'' at the
end;
(C) in subparagraph (B) by striking the period at
the end and inserting ``, or,'';
(D) by inserting after subparagraph (B) the
following:
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions, for the
first 5 fiscal years of the previous 6 fiscal years.'';
and
(E) in the matter following subparagraph (C) (as
added by this paragraph), by striking ``fiscal year
2003'' and inserting ``fiscal year 2008''.
(2) Workload adjustment.--Section 736(c)(2) (21 U.S.C.
379h(c)(2)) is amended--
(A) in the matter preceding subparagraph (A,) by
striking ``2004'' and inserting ``2009'';
(B) in the first sentence of subparagraph (A)--
(i) by striking ``, commercial
investigational new drug applications'' and
inserting ``(adjusted for changes in review
activities)''; and
(ii) by inserting before the period at the
end ``, and the change in the number of
commercial investigational new drug
applications with a submission during the
previous 12-month period (adjusted for changes
in review activities)'';
(C) in subparagraph (B), by adding at the end the
following new sentence: ``Further, any adjustment for
changes in review activities made in setting fees and
fee revenue amounts for fiscal year 2009 may not result
in the total workload adjustment being more than 2
percentage points higher than it would be absent the
adjustment for changes in review activities.''; and
(D) by adding at the end the following:
``(C) The Secretary shall contract with an
independent accounting firm to study the adjustment for
changes in review activities applied in setting fees
for fiscal year 2009 and to make recommendations, if
warranted, on future changes in the methodology for
calculating the adjustment for changes in review
activity. After review of the recommendations by the
independent accounting firm, the Secretary shall make
appropriate changes to the workload adjustment
methodology in setting fees for fiscal years 2010
through 2012. If the study is not conducted, no
adjustment for changes in review activities shall be
made after fiscal year 2009.''.
(3) Rent and rent-related cost adjustment.--Section 736(c)
(21 U.S.C. 379h(c)) is amended--
(A) by redesignating paragraphs (3), (4), and (5)
as paragraphs (4), (5), and (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Rent and rent-related cost adjustment.--Beginning in
fiscal year 2010, the Secretary shall, before making the
adjustments under paragraphs (1) and (2), reduce the fee
amounts established in subsection (b), if actual costs paid for
rent and rent-related expenses are less than $11,721,000. The
reductions made under this paragraph, if any, shall not exceed
the amounts by which costs fell below $11,721,000, and shall
not exceed $11,721,000 in any fiscal year.''.
(4) Final year adjustment.--Section 736(c) (21 U.S.C.
379h(c)) is amended--
(A) in paragraph (4), as redesignated by this
subsection--
(i) by striking ``2007'' each place it
appears and inserting ``2012''; and
(ii) by striking ``2008'' and inserting
``2013''; and
(B) in paragraph (5), as redesignated by this
subsection, by striking ``2002'' and inserting
``2007''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is
amended--
(1) in paragraph (1), in the matter preceding subparagraph
(A), by--
(A) inserting ``to a person who is named as the
applicant'' after ``The Secretary shall grant'';
(B) inserting ``to that person'' after ``a waiver
from or a reduction of one or more fees assessed''; and
(C) striking ``finds'' and inserting
``determines'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(3) by inserting after paragraph (1) the following:
``(2) Evaluation.--For the purpose of determining whether
to grant a waiver or reduction of a fee under paragraph (1),
the Secretary shall consider only the circumstances and assets
of the applicant and any affiliate of the applicant.''; and
(4) in paragraph (4), as redesignated by this subsection,
in subparagraph (A), by inserting before the period at the end
``, and that does not have a drug product that has been
approved under a human drug application and introduced or
delivered for introduction into interstate commerce''.
(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 736(g)(3) (21
U.S.C. 379h(g)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section such
sums as are authorized to be assessed and collected under this
section in each of fiscal years 2008 through 2012.''.
(2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
amended to read as follows:
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, plus the amount
estimated to be collected for fiscal year 2011, exceeds the
amount of fees specified in aggregate in appropriation Acts for
such fiscal years, the aggregate amount in excess shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
(f) Conforming Amendments.--
(1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this
section, is amended--
(A) in paragraph (1)(A), by striking ``subsection
(c)(4)'' each place it appears and inserting
``subsection (c)(5)'';
(B) in paragraph (2), by striking ``subsection
(c)(4)'' and inserting ``subsection (c)(5)''; and
(C) in paragraph (3), by striking ``subsection
(c)(4)'' and inserting ``subsection (c)(5)''.
(2) Section 736A(h)(3), as added by section 4 of this Act,
is amended by striking ``735(3)'' and inserting ``735(d)(3)''.
SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING FEES.
Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is
amended by adding after section 736 the following new section:
``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF
PRESCRIPTION DRUG ADVERTISING.
``(a) Types of Direct-to-Consumer Television Advertisement Review
Fees.--Beginning in fiscal year 2008, the Secretary shall assess and
collect fees in accordance with this section as follows:
``(1) Advisory review fee.--
``(A) In general.--Except as provided in
subparagraph (B), each person that on or after October
1, 2007, submits a proposed direct-to-consumer
television advertisement for advisory review by the
Secretary prior to its initial public dissemination
shall be subject to a fee established under subsection
(c)(3).
``(B) Exception for required submissions.--A
direct-to-consumer television advertisement that is
required to be submitted to the Secretary prior to
initial public dissemination shall not be assessed a
fee unless the sponsor designates it as a submission
for advisory review.
``(C) Payment.--The fee required by subparagraph
(A) shall be due no later than October 1 of the fiscal
year in which the direct-to-consumer television
advertisement shall be submitted to the Secretary for
advisory review.
``(D) Modification of advisory review fee.--
``(i) Late payment.--If, on or before
November 1 of the fiscal year in which the fees
are due, a person has not paid all fees that
were due and payable for advisory reviews
identified in response to the Federal Register
notice described in subsection (c)(3)(A), the
fees shall be regarded as late. Such fees shall
be due and payable 20 days before any direct-
to-consumer television advertisement is
submitted by such person to the Secretary for
advisory review. Notwithstanding any other
provision of this section, such fees shall be
due and payable for each of those advisory
reviews in the amount of 150 percent of the
advisory review fee established for that fiscal
year pursuant to subsection (c)(3).
``(ii) Late notice of submission.--If any
person submits any direct-to-consumer
television advertisements for advisory review
that are in excess of the number identified by
that person in response to the Federal Register
notice described in subsection (c)(3)(A), that
person must pay a fee for each of those
advisory reviews in the amount of 150 percent
of the advisory review fee established for that
fiscal year pursuant to subsection (c)(3). Fees
under this subparagraph shall be due 20 days
before the direct-to-consumer television
advertisement is submitted by such person to
the Secretary for advisory review.
``(E) Limits.--
``(i) In general.--The payment of a fee
under this paragraph for a fiscal year entitles
the person that pays the fee to acceptance for
advisory review by the Secretary of 1 direct-
to-consumer television advertisement and
acceptance of 1 resubmission for advisory
review of the same advertisement. The
advertisement shall be submitted for review in
the fiscal year for which the fee was assessed,
except that a person may carry over no more
than 1 paid advisory review submission to the
next fiscal year. Resubmissions may be
submitted without regard to the fiscal year of
the initial advisory review submission.
``(ii) No refund.--Except as provided by
subsection (f), fees paid under this paragraph
shall not be refunded.
``(iii) No waiver, exemption, or
reduction.--The Secretary shall not grant a
waiver, exemption, or reduction of any fees due
or payable under this section.
``(iv) Non-transferability.--The right to
an advisory review is not transferable, except
to a successor in interest.
``(2) Operating reserve fee.--
``(A) In general.--Each person that, on or after
October 1, 2007, is assessed an advisory review fee
under paragraph (1) shall be subject to an operating
reserve fee established under subsection (d)(2) only in
the first fiscal year in which an advisory review fee
is assessed.
``(B) Payment.--Except as provided in subparagraph
(C), the fee required by subparagraph (A) shall be due
no later than October 1 of the first fiscal year in
which the person is required to pay an advisory review
fee under paragraph (1).
``(C) Late notice of submission.--If, in the first
fiscal year of a person's participation in the Program,
that person submits any direct-to-consumer television
advertisements for advisory review that are in excess
of the number identified by that person in response to
the Federal Register notice described in subsection
(c)(3)(A), that person must pay an operating reserve
fee for each of those advisory reviews equal to the
advisory review fee for each submission established
under paragraph (1)(D)(ii). Fees required by this
subparagraph shall be in addition to the fees required
under subparagraph (B), if any. Fees under this
subparagraph shall be due 20 days before any direct-to-
consumer television advertisement is submitted by such
person to the Secretary for advisory review.
``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection
(a)(1) shall be established to generate revenue amounts of $6,250,000
for each of fiscal years 2008 through 2012, as adjusted pursuant to
subsection (c).
``(c) Adjustments.--
``(1) Inflation adjustment.--Beginning with fiscal year
2009, the revenues established in subsection (b) shall be
adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in
the Consumer Price Index for all urban consumers (all
items; United States city average), for the 12-month
period ending June 30 preceding the fiscal year for
which fees are being established;
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance with section 5332 of title 5, as adjusted by
any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees
stationed in the District of Columbia; or
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions, for the
first 5 fiscal years of the previous 6 fiscal years.
The adjustment made each fiscal year by this subsection shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2008 under this
subsection.
``(2) Workload adjustment.--
``(A) In general.--Beginning with fiscal year 2009,
after the fee revenues established in subsection (b) of
this section are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee
revenues shall be adjusted further for such fiscal year
to reflect changes in the workload of the Secretary
with respect to the submission of proposed direct-to-
consumer television advertisements for advisory review
prior to initial broadcast.
``(B) Determination of workload adjustment.--
``(i) In general.--The workload adjustment
under this paragraph for a fiscal year shall be
determined by the Secretary--
``(I) based upon the number of
direct-to-consumer television
advertisements identified pursuant to
paragraph (3)(A) for that fiscal year,
excluding allowable previously paid
carry over submissions; and
``(II) by multiplying the number of
such advertisements projected for that
fiscal year that exceeds 150 by $27,600
(adjusted each year beginning with
fiscal year 2009 for inflation in
accordance with paragraph (1)).
``(ii) Publication in federal register.--
The Secretary shall publish in the Federal
Register the fee revenues and fees resulting
from the adjustment and the supporting
methodologies.
``(C) Limitation.--Under no circumstances shall the
adjustment result in fee revenues for a fiscal year
that are less than the fee revenues established for the
prior fiscal year.
``(3) Annual fee setting.--
``(A) Number of advertisements.--The Secretary
shall, 120 days before the start of each fiscal year,
publish a notice in the Federal Register requesting any
person to notify the Secretary within 30 days of the
number of direct-to-consumer television advertisements
the person intends to submit for advisory review by the
Secretary in the next fiscal year. Notification to the
Secretary of the number of advertisements a person
intends to submit for advisory review prior to initial
broadcast shall be a legally binding commitment by that
person to pay the annual advisory review fee for that
number of submissions on or before October 1 of the
fiscal year in which the advertisement is intended to
be submitted. A person shall at the same time also
notify the Secretary if such person intends to use a
paid submission from the previous fiscal year under
subsection (a)(1)(E)(i). If such person does not so
notify the Secretary, all submissions for advisory
review shall be subject to advisory review fees.
``(B) Annual fee.--The Secretary shall, 60 days
before the start of each fiscal year, establish, for
the next fiscal year, the direct-to-consumer television
advertisement advisory review fee under subsection
(a)(1), based on the revenue amounts established under
subsection (b), the adjustments provided under this
subsection and the number of direct-to-consumer
television advertisements identified pursuant to
subparagraph (A), excluding allowable previously paid
carry over submissions. The annual advisory review fee
shall be established by dividing the fee revenue for a
fiscal year (as adjusted pursuant to this subsection)
by the number of direct-to-consumer television
advertisements identified pursuant to subparagraph (A),
excluding allowable previously paid carry over
submissions.
``(C) Fiscal year 2008 fee limit.--Notwithstanding
subsection (b), the fee established under subparagraph
(B) for fiscal year 2008 may not be more than $83,000
per submission for advisory review.
``(D) Annual fee limit.--Notwithstanding subsection
(b), the fee established under subparagraph (B) for a
fiscal year after fiscal year 2008 may not be more than
50 percent more than the fee established for the prior
fiscal year.
``(E) Limit.--The total amount of fees obligated
for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for the
process for the advisory review of prescription drug
advertising.
``(d) Operating Reserves.--
``(1) In general.--The Secretary shall establish in the
Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation a Direct-
to-Consumer Advisory Review Operating Reserve, of at least
$6,250,000 in fiscal year 2008, to continue the Program in the
event the fees collected in any subsequent fiscal year pursuant
to subsection (c)(3) do not generate the fee revenue amount
established for that fiscal year.
``(2) Fee setting.--The Secretary shall establish the
operating reserve fee under subsection (a)(2)(A) for each
person required to pay the fee by multiplying the number of
direct-to-consumer television advertisements identified by that
person pursuant to subsection (c)(3)(A) by the advisory review
fee established pursuant to subsection (c)(3) for that fiscal
year. In no case shall the operating reserve fee assessed be
less than the operating reserve fee assessed if the person had
first participated in the Program in fiscal year 2008.
``(3) Use of operating reserve.--The Secretary may use
funds from the reserves under this subsection only to the
extent necessary in any fiscal year to make up the difference
between the fee revenue amount established for that fiscal year
under subsection (b) and the amount of fees collected for that
fiscal year pursuant to subsection (a), or to pay costs of
ending the Program if it is terminated pursuant to subsection
(f) or if it is not reauthorized after fiscal year 2012.
``(4) Refund of operating reserves.--Within 120 days of the
end of fiscal year 2012, or if the Program is terminated
pursuant to subsection (f), the Secretary, after setting aside
sufficient operating reserve amounts to terminate the Program,
shall refund all amounts remaining in the operating reserve on
a pro rata basis to each person that paid an operating reserve
fee assessment. In no event shall the refund to any person
exceed the total amount of operating reserve fees paid by such
person pursuant to subsection (a)(2).
``(e) Effect of Failure To Pay Fees.--Notwithstanding any other law
or regulation of the Secretary, a submission for advisory review of a
direct-to-consumer television advertisement submitted by a person
subject to fees under subsection (a) shall be considered incomplete and
shall not be accepted for review by the Secretary until all fees owed
by such person under this section have been paid.
``(f) Effect of Inadequate Funding of Program.--
``(1) First fiscal year.--If on November 1, 2007, or 120
days after enactment of the Prescription Drug User Fee
Amendments of 2007, whichever is later, the Secretary has
received less than $11,250,000 in advisory review fees and
operating reserve fees combined, the Program shall be
terminated and all collected fees shall be refunded.
``(2) Subsequent fiscal years.--Beginning in fiscal year
2009, if, on November 1 of a fiscal year, the combination of
the operating reserves, annual fee revenues from that fiscal
year, and unobligated fee revenues from prior fiscal years is
less than $9,000,000, adjusted for inflation (in accordance
with subsection (c)(1)), the Program shall be terminated, and
the Secretary shall notify all participants, retain any money
from the unused advisory review fees and the operating reserves
needed to terminate the Program, and refund the remainder of
the unused fees and operating reserves. To the extent required
to terminate the Program, the Secretary shall first use
unobligated advisory review fee revenues from prior fiscal
years, then the operating reserves, and then unused advisory
review fees from the relevant fiscal year.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the process for the advisory review of prescription
drug advertising.
``(2) Collections and appropriation acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation for such fiscal year; and
``(B) shall be available for obligation only if
appropriated budget authority continues to support at
least the total combined number of full-time equivalent
employees in the Food and Drug Administration, Center
for Drug Evaluation and Research, Division of Drug
Marketing, Advertising, and Communications, and the
Center for Biologics Evaluation and Research,
Advertising and Promotional Labeling Branch supported
in fiscal year 2007.
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section not
less than $6,250,000 for each of fiscal years 2008, 2009, 2010,
2011, and 2012, as adjusted to reflect adjustments in the total
fee revenues made under this section, plus amounts collected
for the reserve fund under subsection (d).
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
collected under this section pursuant to appropriation Acts for
a subsequent fiscal year.
``(h) Definitions.--For purposes of this section:
``(1) The term `advisory review' means reviewing and
providing advisory comments regarding compliance of a proposed
advertisement with the requirements of this Act prior to its
initial public dissemination.
``(2) The term `carry over submission' means a submission
for an advisory review for which a fee was paid in a fiscal
year that is submitted for review in the following fiscal year.
``(3) The term `direct-to-consumer television
advertisement' means an advertisement for a prescription drug
product as defined in section 735(3) intended to be displayed
on any television channel for less than 2 minutes.
``(4) The term `person' includes an individual, a
partnership, a corporation, and an association, and any
affiliate thereof or successor in interest.
``(5) The term `Program' means the Program to assess,
collect, and use fees for the advisory review of prescription
drug advertising established by this section.
``(6) The term `process for the advisory review of
prescription drug advertising' means the activities necessary
to review and provide advisory comments on proposed direct-to-
consumer television advertisements prior to public
dissemination and, to the extent the Secretary has additional
staff resources available under the Program that are not
necessary for the advisory review of direct-to-consumer
television advertisements, the activities necessary to review
and provide advisory comments on other proposed advertisements
and promotional material prior to public dissemination.
``(7) The term `resources allocated for the process for the
advisory review of prescription drug advertising' means the
expenses incurred in connection with the process for the
advisory review of prescription drug advertising for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers, employees, and committees, and to
contracts with such contractors;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies;
``(D) collection of fees under this section and
accounting for resources allocated for the advisory
review of prescription drug advertising; and
``(E) terminating the Program under subsection
(f)(2), if necessary.
``(8) The term `resubmission' means a subsequent submission
for advisory review of a direct-to-consumer television
advertisement that has been revised in response to the
Secretary's comments on an original submission. A resubmission
may not introduce significant new concepts or creative themes
into the television advertisement.
``(9) The term `submission for advisory review' means an
original submission of a direct-to-consumer television
advertisement for which the sponsor voluntarily requests
advisory comments before the advertisement is publicly
disseminated.''.
SEC. 5. SAVINGS CLAUSE.
Notwithstanding section 509 of the Prescription Drug User Fee
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the
amendments made by this Act, part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act, as in effect on the day
before the date of enactment of this Act, shall continue to be in
effect with respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October 1, 2002,
but before October 1, 2007, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2008.
SEC. 6. TECHNICAL AMENDMENTS.
(a) Section 737 (21 U.S.C. 379i) is amended in the matter preceding
paragraph (1), by striking ``subchapter'' and inserting ``part''.
(b) Section 739 (21 U.S.C. 379j-11) is amended in the matter
preceding paragraph (1), by striking ``subchapter'' and inserting
``part''.
SEC. 7. EFFECTIVE DATES.
(a) In General.--Except as provided in subsection (b), the
amendments made by this Act shall take effect October 1, 2007.
(b) Exception.--The amendment made by section 4 of this Act shall
take effect on the date of enactment of this Act.
SEC. 8. SUNSET DATE.
Sections 735, 736, and 736A of the Federal Food, Drug, and Cosmetic
Act shall cease to be effective on October 1, 2012.
<all>
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
Measure laid before Senate by unanimous consent. (consideration: CR S5270-5303; text of measure as reported in Senate: CR S5270-5294)
Considered by Senate. (consideration: CR S5325-5329, S5332-5362, S5367, S5368-5371, S5372-5379, S5380-5385, S5387-5388)
The committee reported substitute amendment was modified by Unanimous Consent. (text as modified: CR S5333-5361)
Considered by Senate. (consideration: CR S5444-5485, S5486-5492)
Considered by Senate. (consideration: CR S5526-5558)
Cloture motion on the committee substitute amendment as modified presented in Senate. (consideration: CR S5556-5557)
Cloture motion on the measure presented in Senate. (consideration: CR S5557)
Considered by Senate. (consideration: CR S5634-5651)
Cloture on the committee substitute amendment as modified invoked in Senate by Yea-Nay Vote. 82 - 8. Record Vote Number: 152. (consideration: CR S5641-5642; text: CR S5641)
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Considered by Senate. (consideration: CR S5682-5686, S5689-5707)
Considered by Senate. (consideration: CR S5759-5824)
The committee substitute as amended agreed to by Unanimous Consent.
Cloture motion on the bill withdrawn by unanimous consent in Senate.
Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 93 - 1. Record Vote Number: 157.(text: CR S5773-5822)
Roll Call #157 (Senate)Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 93 - 1. Record Vote Number: 157. (text: CR S5773-5822)
Roll Call #157 (Senate)Received in the House.
Message on Senate action sent to the House.
Held at the desk.