Drug Regulation Reform Act of 1979

(Measure passed Senate, amended)

Drug Regulation Reform Act of 1979 - =Title I: Amendments to Federal Food, Drug, and Cosmetic Act= - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "interstate commerce" to include commerce that affects commerce between any State or Territory and any place outside of such jurisdiction, and commerce within the District of Columbia or any other Territory not organized with a legislative body. Stipulates that where the processing, manufacture, distribution, holding, and dispensing of a drug occur entirely within a single State, and such activities have been expressly authorized by the laws of such State, the provisions of such Act shall not apply.

Expands the definition of "person" subject to the coverage of the Act to include an agency of government. Redefines "counterfeit drug" to include a prescription drug in a finished solid form which: (1) contains the same active ingredients in the same strength as another prescription drug in the same form; (2) is introduced into interstate commerce after the other drug was lawfully introduced; and (3) is so nearly identical in overall appearance to the other drug as to create a substantial likelihood that consumers will not be able to distinguish between them.

Prohibits the inclusion of false, misleading, or incomplete information in any document submitted to or inspected by the Secretary of Health, Education and Welfare. Prohibits the movement of a drug in violation of an embargo order or the removal or alteration of any mark or label required by such order to identify such drug. Establishes criminal penalties for negligent commission of prohibited acts.

Requires any new drug to meet standards of identity, stability, and bioavailability, as well as of strength, quality, and purity. Stipulates that no drug shall be deemed adulterated if it fails to meet such standards if its difference from such standards is plainly stated on its labeling.

Requires drug manufacturers and distributors to prepare information labeling for patients containing: (1) a summary of the benefits and risks of use of a drug; (2) adequate directions for use; and (3) information about proper storage and handling. Requires pharmacies to keep a book available to patients containing the labeling information for the 100 most frequently sold prescription drugs.

Disallows the withholding of patient information labeling from a patient by a practitioner unless the Secretary determines that it would be detrimental to the health of the patient to deny practitioners the authority to withhold such labeling.

Authorizes the Secretary of Health, Education, and Welfare to require retail drug sellers to post the retail prices of the 50 most frequently sold prescription drugs which are designated by the Secretary.

Requires manufacturers and distributors to prepare information labeling for practitioners regarding pharmacological classification, indications, contraindications, and other pertinent matters. Stipulates that applications for the introduction of new drugs into interstate commerce shall not be approved until the required patient information labeling has been approved by the Secretary.

Directs the Secretary to afford private organizations the opportunity to prepare, publish, and distribute a comprehensive index of all prescription drugs and revisions thereof; and if, at the end of three years following the establishment of labeling regulations by the Secretary, no private index is forthcoming, to prepare one with drugs arranged by diagnostic and therapeutic categories and listed by established name.

Permits the Secretary, by order, to require adequate notification to patients, practitioners, pharmacists, and all other necessary persons regarding any substantial risk of illness or injury posed by a drug, if such notification is an effective means to eliminate or reduce such risk.

Authorizes the Secretary to disseminate information regarding the safety, effectiveness, and proper use of drugs.

Specifies requirements for any promotion labeling issued by or on behalf of a drug manufacturer or any other person under whose firm or proprietary name the drug is distributed.

Prohibits the provision of any services or transfer of any property worth more than $10.00 by a manufacturer or distributor with the intent to influence any specified person to buy, prescribe, or dispense one or more particular drugs. Prohibits the distribution of free samples by a manufacturer or distributor, except in specified circumstances. Prohibits any pharmacist or agent from disclosing any prescription information to any person except: (1) the patient, or in a medical emergency where the patient lacks the capacity to request disclosure, to a person addressing such emergency; (2) the practitioner or another practitioner authorized by the patient to receive such information; (3) another pharmacist for purposes of filling or refilling it; (4) a State or Federal officer or employee under certain circumstances; or (5) a person who has demonstrated to the Secretary an appropriate academic, market, or other research purpose. Prohibits manufacturers and distributors from obtaining or attempting to obtain prescription information.

Prohibits a person from introducing any drug intended for use by humans into interstate commerce unless an application is filed with and approved by the Food and Drug Administration (FDA). Exempts certain drugs from such requirement. Permits an applicant to submit a releasable summary of all the reports of investigations (in lieu of the full reports themselves) conducted to assess the risks of a drug and evaluate its effectiveness. Stipulates that the Secretary shall not require that such summary contain: (1) information in greater detail than required of a report for publication in a reputable medical journal; (2) information relating to non-germane investigations; (3) information concerning other drugs; or (4) trade secrets. Revises procedures for the review of such applications by the FDA.

Changes the ground for immediate suspension of approval of a drug application from "imminent hazard to the public health" to "unreasonable risk of illness or injury to any segment of the population." Allows the Secretary to delegate suspension authority to the Commissioner of Food and Drugs. Stipulates that whenever protection of the public health permits, the Secretary shall consult with the manufacturer of the drug and other concerned parties prior to suspending any application. Permits revocation of an application where the applicant has continued to fail substantially to comply with a requirement or prohibition and such failure, after notice by the FDA, has not been corrected within a reasonable time. Directs the Secretary to prescribe an abbreviated application procedure for certain drugs.

Requires clinical investigators to obtain voluntary informed consent, in writing, of all human beings, or their representatives, to whom a drug is administered in order to investigate the benefits and risks of such drug.

Establishes new procedures for drug research investigations. Requires any person who intends to conduct an investigation to obtain a registration from the Secretary. Directs the Secretary to authorize certain institutions to issue registrations for and supervise drug research investigations.

Directs the Secretary to issue written, non-mandatory guidelines regarding protocols and methods for conducting drug investigations. Requires the Secretary to establish informal and expeditious procedures for impartially reviewing and resolving scientific disputes.

Specifies factors of the health benefits versus risks analysis required for the determination of the safety of a drug.

Requires the Secretary to approve the application for a drug proven safe but not proven effective if: (1) it is to be prescribed to treat a life-threatening or severely debilitating condition; (2) there is no other effective method of treatment; (3) and there is significant, if not substantial, scientific evidence that such drug is effective.

Exempts homeopathic drugs from certain new drug application requirements.

Defines "voluntary and informed consent" for the purposes of this Act.

Eliminates existing specified requirements for the certification of drugs containing insulin and antibiotic drugs.

Allows the Secretary to impose additional requirements relating to distribution and dispensing, post-marketing surveillance, further scientific investigations, and batch certification as a condition for approval of any drug application. Specifies procedures for the imposition of such requirements.

Authorizes the appointment of advisory committees to assist in making the determinations authorized by such Act.

Authorizes the Secretary to subpoena witnesses and records in any matter relating to implementation or enforcement of such Act.

Prohibits any State from imposing requirements regarding the packaging and labeling of any drug which is in addition to or different from a comparable requirement imposed under this Act. Permits the Secretary to exempt a State from such prohibition if such action would significantly enhance the public health within such State and would not impose an undue burden on interstate commerce.

Permits the export of an unapproved drug if the Secretary determines that such exportation is not contrary to public health and safety and has the approval of the importing country. Establishes a Task Force on Drug Export Policy to develop a Drug Export Policy Plan. Specifies the factors the Task Force must consider in developing such Plan.

Provides that certain drugs subject to the Food and Drugs Act of June 30, 1906, shall be deemed to have an approved application under the Federal Food, Drug, and Cosmetic Act and shall be subject to the requirements of such Act.

=Title II: Office for Drug Science= - Amends the Public Health Service Act to establish in the Department of Health, Education, and Welfare the Office for Drug Science. Directs the Office to conduct an ongoing program of drug science policy research, either directly or by grant or contract, and an ongoing review and analysis of drug use in the United States which shall result in an annual Drug Experience Assessment Report. Directs the Office to examine the appropriateness of the requirement of "substantial evidence" of effectiveness and the appropriateness of the regulations and procedures relied upon by the Commissioner in implementing such requirement and to report its findings to the Congress.

Directs the Secretary of Health, Education, and Welfare to make grants to schools of medicine, osteopathy, dentistry, pharmacy, podiatry, nursing and training centers for allied health professions for the expansion of existing programs and the establishment of new programs. Authorizes appropriations for demonstration projects, traineeships, and fellowships.

Establishes a National Advisory Board on Drug Science to assist the Secretary and to review and comment on the activities of the Office. Terminates the Board on September 30, 1983.

=Title III: Establishment of the Food and Drug Administration= - Establishes within the Department of Health, Education, and Welfare the Food and Drug Administration. Provides that the Commissioner of Food and Drugs shall be appointed by the President, by and with the advice and consent of the Senate. Specifies the powers and duties of the Commissioner. Establishes conflict-of-interest standards for consultants working with the Administration. Transfers to the Administration specified functions under specified Acts.

Repeals the Filled Milk Act which prohibits the manufacture, shipment, or delivery for shipment in interstate or foreign commerce of any filled milk.