Pandemic Preparedness and Response Act - Amends the Public Health Service Act to require the President to appoint a National Director of Pandemic Preparedness and Response to strengthen, expand, and coordinate domestic pandemic influenza preparedness activities.
Establishes the Pandemic Influenza Preparedness Policy Coordinating Committee to develop an Interagency Preparedness Plan.
Requires states to have an approved state preparedness plan as a condition of receiving certain funds related to bioterrorism.
Provides for the integration and coordination of public and private influenza surveillance activities.
Directs the Secretary of Health and Human Services to: (1) procure antivirals, developed vaccines, and essential medications for the Strategic National Stockpile; (2) develop a national system for tracking and distributing antiviral medications and vaccines; and (3) assist other counties in preparation for, and response to, pandemic influenza.
Provides for the expansion and intensification of influenza research.
Directs the Secretary to contract with the Institute of Medicine to study topics related to the pandemic influenza.
Establishes the National Pandemic Influenza Economics Advisory Committee.
Requires the Secretary of Agriculture to expand and intensify efforts to prevent pandemic influenza.
Requires the Secretary of Health and Human Services to: (1) enter into contracts with manufacturers to produce additional necessary doses of the influenza vaccine; and (2) develop a national plan for responding to potential influenza vaccine shortages.
Sets forth prohibitions against charging excessive prices during a public health emergency for, reporting false pricing information to the Secretary about, or employing a manipulative or deceptive device or contrivance in connection with the purchase or sale of, drugs, devices, or biologics for the prevention or treatment of influenza at wholesale.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1821 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 1821
To amend the Public Health Service Act with respect to preparation for
an influenza pandemic, including an avian influenza pandemic, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 5, 2005
Mr. Reid (for himself, Mr. Obama, Mr. Bayh, Mr. Kennedy, Mr. Harkin,
Mr. Durbin, Mr. Reed, Mr. Dodd, Mrs. Murray, Ms. Mikulski, Mrs.
Clinton, Mr. Kohl, and Mr. Dayton) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act with respect to preparation for
an influenza pandemic, including an avian influenza pandemic, 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.
This Act may be cited as the ``Pandemic Preparedness and Response
Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) The Department of Health and Human Services reports
that an influenza pandemic has a greater potential to cause
rapid increases in death and illness than virtually any other
natural health threat.
(2) Three pandemics occurred during the 20th century: the
Spanish flu pandemic in 1918, the Asian flu pandemic in 1957,
and the Hong Kong flu pandemic in 1968. The Spanish flu
pandemic was the most severe, causing over 500,000 deaths in
the United States and more than 20,000,000 deaths worldwide.
(3) The Centers for Disease Control and Prevention has
estimated conservatively that up to 207,000 Americans would
die, and up to 734,000 would be hospitalized, during the next
pandemic. The costs of the pandemic, including the total direct
costs associated with medical care and indirect costs of lost
productivity and death, are estimated at between
$71,000,000,000 and $166,500,000,000. These costs do not
include the economic effects of pandemic on commerce and
society.
(4) Recent studies suggest that avian influenza strains,
which are endemic in wild birds and poultry populations in some
countries, are becoming increasingly capable of causing severe
disease in humans and are likely to cause the next pandemic
flu.
(5) In 2004, 8 nations--Thailand, Vietnam, Indonesia,
Japan, Laos, China, Cambodia, and the Republic of Korea--
experienced outbreaks of avian flu (H5N1) among poultry flocks.
Cases of human infections were confirmed in Thailand, Cambodia,
Indonesia, and Vietnam (including a possible human-to-human
infection in Thailand).
(6) As of September 29, 2005, 116 confirmed human cases of
avian influenza (H5N1) have been reported, 60 of which resulted
in death. Of these cases, 91 were in Vietnam, 17 in Thailand, 4
in Cambodia, and 4 in Indonesia.
(7) On February 21, 2005, Dr. Julie Gerberding, Director of
the Centers for Disease Control and Prevention, stated that
``this is a very ominous situation for the globe ... the most
important threat we are facing right now.''.
(8) On February 23, 2005, Dr. Shigeru Omi, Asia regional
director of the World Health Organization (WHO), stated with
respect to the avian flu, ``We at WHO believe that the world is
now in the gravest possible danger of a pandemic.''.
(9) The best defense against influenza pandemics is a
heightened global surveillance system. In many of the nations
where avian flu (H5N1) has become endemic the early detection
capabilities are severely lacking, as is the transparency in
the health systems.
(10) In addition to surveillance, pandemic preparedness
requires domestic and international coordination and
cooperation to ensure an adequate medical response, including
communication and information networks, public health measures
to prevent spread, use of vaccination and antivirals, provision
of health outpatient and inpatient services, and maintenance of
core public functions.
SEC. 3. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 et
seq.) is amended by adding at the end the following:
``Subtitle 3--Pandemic Influenza Preparedness
``SEC. 2141. DEFINITION.
``For purposes of this subtitle, the term `State' shall have the
meaning given such term in section 2(f) and shall include Indian tribes
and tribal organizations (as defined in section 4(b) and 4(c) of the
Indian Self-Determination and Education Assistance Act).
``SEC. 2142. NATIONAL DIRECTOR OF PANDEMIC PREPAREDNESS AND RESPONSE.
``(a) Appointment.--The President shall appoint an individual to
serve as the National Director of Pandemic Preparedness and Response
(referred to in this section as the `Director') within the Executive
Office of the President.
``(b) Responsibilities.--The Director shall--
``(1) serve as the chairperson of the Pandemic Influenza
Preparedness Policy Coordinating Committee (as described in
section 2143);
``(2) coordinate the Federal interagency preparation for a
pandemic;
``(3) coordinate the Federal interagency response to a
pandemic;
``(4) oversee approval of State pandemic plans to ensure
nationwide preparedness standards and regional coordination as
provided for under section 2144(b)(3);
``(5) ensure coordination between the governmental and non-
governmental economic and finance infrastructure as it relates
to pandemic preparedness and response;
``(6) as soon as practicable, finalize a National Pandemic
Influenza Preparedness Plan that describes programs and
activities to decrease the burden of disease, minimize social
disruption, and reduce economic impact from an influenza
pandemic;
``(7) implement the National Pandemic Influenza
Preparedness Plan;
``(8) make the National Pandemic Influenza Preparedness
Plan available to Congress, and the public as appropriate;
``(9) submit to Congress an annual budget request related
to the National Pandemic Influenza Preparedness Plan;
``(10) report to Congress on a biannual basis progress
regarding the implementation of the National Pandemic Influenza
Preparedness Plan;
``(11) address any deficiencies in the National Pandemic
Influenza Preparedness Plan as determined by the Government
Accountability Office report under subsection (c);
``(12) coordinate the provision of technical assistance
related to pandemic preparedness across Federal agencies,
States, and local governments;
``(13) ensure outreach and education campaigns are
conducted related to preparedness for businesses, health care
providers, and the public;
``(14) address supply chain issues related to a pandemic;
``(15) ensure that the National Pandemic Influenza
Preparedness Plan includes a specific focus on traditionally
underserved populations, including low-income, racial and
ethnic minorities, immigrants, and uninsured populations; and
``(16) hire staff, request information, assistance, or
detailees from other Federal agencies, and carry out other
activities related to staffing and administration.
``(c) GAO Report.--
``(1) In general.--Not later than 60 days after the
Director has finalized the National Pandemic Influenza
Preparedness Plan under subsection (b)(5), the Government
Accountability Office shall submit to the Director and Congress
a report concerning the National Pandemic Influenza
Preparedness Plan.
``(2) Requirements.--At a minimum, the report under
paragraph (1) shall evaluate the ability of the National
Pandemic Influenza Preparedness Plan to--
``(A) address the organizational structure and
chain of command, both in the Federal government and at
the State level;
``(B) ensure adequate laboratory surveillance of
influenza, including the ability to isolate and subtype
influenza viruses year round;
``(C) improve vaccine research, development, and
production;
``(D) procure adequate doses of antivirals for
treatment.
``(E) develop systems for tracking and distributing
antiviral medication and vaccines;
``(F) prioritize who would receive antivirals and
vaccines based on limited supplies;
``(G) stockpile medical and safety equipment for
health care workers and first responders;
``(H) assure surge capacity capabilities for health
care providers and institutions;
``(I) secure a backup health care workforce in the
event of a pandemic;
``(J) ensure the availability of food, water, and
other essential items during a pandemic;
``(K) provide guidance on needed State and local
authority to implement public health measures such as
isolation or quarantine;
``(L) maintain core public functions, including
public utilities, refuse disposal, mortuary services,
transportation, police and firefighter services, and
other critical services;
``(M) establish networks that provide alerts and
other information for health care providers;
``(N) communicate with the public with respect to
prevention and obtaining care during a pandemic; and
``(O) provide security for first responders and
other medical personnel and volunteers, hospitals,
treatment centers, isolation and quarantine areas, and
transportation and delivery of resources.
``SEC. 2143. POLICY COORDINATING COMMITTEE ON PANDEMIC INFLUENZA
PREPAREDNESS.
``(a) In General.--There is established the Pandemic Influenza
Preparedness Policy Coordinating Committee (referred to in this section
as the `Committee').
``(b) Membership.--
``(1) In general.--The Committee shall be composed of--
``(A) the Secretary;
``(B) the Secretary of Homeland Security;
``(C) the Secretary of Agriculture;
``(D) the Secretary of State;
``(E) the Secretary of Defense;
``(F) the Secretary of Commerce;
``(G) the Administrator of the Environmental
Protection Agency;
``(H) the Secretary of Transportation;
``(I) the Secretary of Veterans Affairs; and
``(J) other representatives as determined
appropriate by the Chair of the Committee.
``(2) Chair.--The Director of Pandemic Preparedness and
Response shall serve as the Chair of the Committee.
``(3) Term.--The members of the Committee shall serve for
the life of the Committee.
``(c) Meetings.--
``(1) In general.--The Committee shall meet not less often
than 2 times per year at the call of the Chair or as determined
necessary by the President.
``(2) Representation.--A member of the Committee under
subsection (b) may designate a representative to participate in
Committee meetings, but such representative shall hold the
position of at least an assistant secretary or equivalent
position.
``(d) Duties of the Committee.--
``(1) Preparedness plans.--Each member of the Committee
shall submit to the Committee a pandemic influenza preparedness
plan for the agency involved that describes--
``(A) initiatives and proposals by such member to
address pandemic influenza (including avian influenza)
preparedness; and
``(B) any activities and coordination with
international entities related to such initiatives and
proposals.
``(2) Interagency plan and recommendations.--
``(A) In general.--
``(i) Preparedness plan.--Based on the
preparedness plans described under paragraph
(1), and not later than 90 days after the date
of enactment of this subtitle, the Committee
shall develop an Interagency Preparedness Plan
that integrates and coordinates such
preparedness plans.
``(ii) Content of plan.--The Interagency
Preparedness Plan under clause (i) shall
include a description of--
``(I) departmental or agency
responsibility and accountability for
each component of such plan;
``(II) funding requirements and
sources;
``(III) international collaboration
and coordination efforts; and
``(IV) recommendations and a
timeline for implementation of such
plan.
``(B) Report.--
``(i) In general.--The Committee shall
submit to the President and Congress, and make
available to the public as appropriate, a
report that includes the Interagency
Preparedness Plan.
``(ii) Updated report.--The Committee shall
submit to the President and Congress, and make
available to the public as appropriate, on a
biannual basis, an update of the report that
includes a description of--
``(I) progress made toward plan
implementation, as described under
clause (i); and
``(II) progress of the domestic
preparedness programs under section
2144 and of the international
assistance programs under section 2145.
``(C) Consultation with international entities.--In
developing the preparedness plans described under
subparagraph (A) and the report under subparagraph (B),
the Committee should consult with representatives from
the World Health Organization, the World Organization
for Animal Health, and other international bodies, as
appropriate.
``(e) Application of FACA.--Notwithstanding the Federal Advisory
Committee Act, non-government individuals and entities may participate
in the activities of the Committee.
``SEC. 2144. DOMESTIC PANDEMIC INFLUENZA PREPAREDNESS ACTIVITIES.
``(a) Pandemic Preparedness Activities.--The Director of Pandemic
Preparedness and Response shall strengthen, expand, and coordinate
domestic pandemic influenza preparedness activities.
``(b) State Preparedness Plan.--
``(1) In general.--As a condition of receiving funds from
the Centers for Disease Control and Prevention or the Health
Resources and Services Administration related to bioterrorism,
a State shall--
``(A) designate an official or office as
responsible for pandemic influenza preparedness;
``(B) submit to the Director of the Centers for
Disease Control and Prevention a Pandemic Influenza
Preparedness Plan described under paragraph (2); and
``(C) have such Preparedness Plan approved in
accordance with this subsection.
``(2) Preparedness plan.--
``(A) In general.--The Pandemic Influenza
Preparedness Plan required under paragraph (1) shall
address--
``(i) human and animal surveillance
activities, including capacity for
epidemiological analysis, isolation and
subtyping of influenza viruses year-round,
including for avian influenza among domestic
poultry, and reporting of information across
human and veterinary sectors;
``(ii) methods to ensure surge capacity in
hospitals, laboratories, outpatient healthcare
provider offices, medical suppliers, and
communication networks;
``(iii) assisting the recruitment and
coordination of national and State volunteer
banks of healthcare professionals;
``(iv) distribution of vaccines,
antivirals, and other treatments to priority
groups, and monitor effectiveness and adverse
events;
``(v) networks that provide alerts and
other information for healthcare providers and
organizations at the National, State, and
regional level;
``(vi) communication with the public with
respect to prevention and obtaining care during
pandemic influenza;
``(vii) maintenance of core public
functions, including public utilities, refuse
disposal, mortuary services, transportation,
police and firefighter services, and other
critical services;
``(viii) provision of security for--
``(I) first responders and other
medical personnel and volunteers;
``(II) hospitals, treatment
centers, and isolation and quarantine
areas;
``(III) transport and delivery of
resources, including vaccines,
medications and other supplies; and
``(IV) other persons or functions
as determined appropriate by the
Secretary;
``(ix) the acquisition of necessary legal
authority for pandemic activities;
``(x) integration with existing national,
State, and regional bioterrorism preparedness
activities or infrastructure;
``(xi) coordination among public and
private health sectors with respect to
healthcare delivery, including mass vaccination
and treatment systems, during pandemic
influenza; and
``(xii) coordination with Federal pandemic
influenza preparedness activities.
``(B) Underserved populations.--The Pandemic
Influenza Preparedness Plan required under paragraph
(1) shall include a specific focus on surveillance,
prevention, and medical care for traditionally
underserved populations, including low-income, racial
and ethnic minority, immigrant, and uninsured
populations.
``(3) Approval of state plan.--
``(A) In general.--The Director of Pandemic
Preparedness and Response, in collaboration with the
Pandemic Influenza Preparedness Policy Coordinating
Committee, shall develop criteria to rate State
Pandemic Influenza Preparedness Plans required under
paragraph (1) and determine the minimum rating needed
for approval.
``(B) Timing of approval.--Not later than 90 days
after a State submits a State Pandemic Influenza
Preparedness Plan as required under paragraph (1), the
Director of Pandemic Preparedness and Response shall
make a determination regarding approval of such Plan.
``(4) Reporting of state plan.--All Pandemic Influenza
Preparedness Plans submitted and approved under this section
shall be made available to Congress, State officials, and the
public as determined appropriate by the Director.
``(5) Assistance to states.--The Centers for Disease
Control and Prevention and the Health Resources and Services
Administration may provide assistance to States in carrying out
this subsection, or implementing an approved State Pandemic
Influenza Preparedness Plan, which may include the detail of an
officer to approved domestic pandemic sites or the purchase of
equipment and supplies.
``(6) Waiver.--The Director of Pandemic Preparedness and
Response may grant a temporary waiver of 1 or more of the
requirements under this subsection.
``(c) Domestic Surveillance.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Agriculture, shall establish minimum thresholds
for States with respect to adequate surveillance for pandemic
influenza, including possible pandemic avian influenza.
``(2) Assistance to states.--
``(A) In general.--The Secretary, in coordination
with the Secretary of Agriculture, shall provide
assistance to States and regions to meet the minimum
thresholds established under paragraph (1).
``(B) Types of assistance.--Assistance provided to
States under subparagraph (A) may include--
``(i) the establishment or expansion of
State surveillance and alert systems, including
the Sentinel Physician Surveillance System and
122 Cities Mortalities Report System;
``(ii) the provision of equipment and
supplies;
``(iii) support for epidemiological
analysis and investigation of novel strains;
``(iv) the sharing of biological specimens
and epidemiological and clinical data within
and across States; and
``(v) other activities determined
appropriate by the Secretary.
``(3) Detail of officers.--The Secretary may detail
officers to States for technical assistance as needed to carry
out this subsection.
``(d) Private Sector Involvement.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
the Administrator of the Health Resources and Services
Administration, and in coordination with private sector
entities, shall integrate and coordinate public and private
influenza surveillance activities, as appropriate.
``(2) Grant program.--
``(A) In general.--In carrying out the activities
under paragraph (1), the Secretary may establish a
grant program, or expand existing grant programs, to
provide funding to eligible entities to coordinate or
integrate as appropriate, pandemic preparedness
surveillance activities between States and private
health sector entities, including hospitals, health
plans, and other health systems.
``(B) Eligibility.--To be eligible to receive a
grant under subparagraph (A), an entity shall submit an
application at such time, in such manner, and
containing such information as the Secretary may
require.
``(C) Use of funds.--Funds under a grant under
subparagraph (A) may be used to--
``(i) develop and implement surveillance
protocols for patients in outpatient and
hospital settings;
``(ii) establish a communication alert plan
for patients for reportable signs and symptoms
that may suggest influenza;
``(iii) plan for the vaccination of
populations and, if appropriate, dissemination
of antiviral drugs;
``(iv) purchase necessary equipment and
supplies;
``(v) increase laboratory testing and
networking capacity;
``(vi) conduct epidemiological and other
analyses; or
``(vii) report and disseminate data.
``(D) Detail of officers.--The Secretary may detail
officers to grantees under subparagraph (A) for
technical assistance.
``(E) Requirement.--As a condition of receiving a
grant under subparagraph (A), a State shall have a plan
to meet minimum thresholds for State influenza
surveillance established by the Director of the Centers
for Disease Control and Prevention in coordination with
the Secretary of Agriculture under subsection (b).
``(e) Procurement of Antivirals for the Strategic National
Stockpile.--The Secretary shall take immediate action to procure for
the Strategic National Stockpile described under section 319F-2
antivirals needed to prevent or treat infection during a pandemic
influenza, including possible pandemic avian influenza, for at least 50
percent of the population.
``(f) Procurement of Vaccines for the Strategic National
Stockpile.--Subject to development and testing of potential vaccines
for pandemic influenza, including possible pandemic avian influenza,
the Secretary shall determine the minimum number of doses of vaccines
needed to prevent infection during at least the first wave of pandemic
influenza for health professionals (including doctors, nurses, mental
health professionals, pharmacists, laboratory personnel,
epidemiologists, virologists, and public health practitioners), core
public utility employees, and those persons expected to be at high risk
for serious morbidity and mortality from pandemic influenza, and take
immediate steps to procure this minimum number of doses for the
Strategic National Stockpile described under section 319F-2.
``(g) Procurement of Essential Medications.--The Secretary shall,
as soon as is practicable, take action to procure for the Strategic
National Stockpile essential medications and other supplies that may be
needed in the event of a pandemic.
``(h) National Tracking and Distribution System for Vaccines and
Antivirals.--
``(1) In general.--The Secretary shall develop and
implement a national system for the tracking and distribution
of antiviral medications and vaccines in order to prepare and
respond to pandemic influenza.
``(2) System.--The system developed under paragraph (1)
shall--
``(A) allow for the electronic tracking of all
domestically available antiviral medication and
vaccines for pandemic influenza;
``(B) anticipate shortages, and alert officials if
shortages are expected in such medications and
vaccines;
``(C) target distribution to high-risk groups,
including health professionals and relief personnel and
other individuals determined to be most susceptible to
disease or death from pandemic flu;
``(D) ensure equitable distribution, particularly
across low-income and other underserved groups; and
``(E) integrate with existing State and local
systems as appropriate.
``(i) Reimbursements.--The Secretary shall have the authority to
reimburse State and local health departments for expenditures related
to influenza vaccine purchase and administration during a public health
emergency under section 319(a).
``SEC. 2145. PROPOSAL FOR INTERNATIONAL FUND TO SUPPORT PANDEMIC
INFLUENZA CONTROL.
``(a) In General.--The Director of Pandemic Preparedness and
Response should submit to the Director of the World Health Organization
a proposal to study the feasibility of establishing a fund, (referred
to in this section as the `Pandemic Fund') to support pre-pandemic
influenza control, surveillance, and relief activities conducted in
countries affected by avian influenza or other viruses likely to cause
pandemic influenza.
``(b) Content of Proposal.--The proposal submitted under subsection
(a) shall describe, with respect to the Pandemic Fund--
``(1) funding sources;
``(2) administration;
``(3) application process by which a country may apply to
receive assistance from such Fund;
``(4) factors used to make a determination regarding a
submitted application, which may include--
``(A) the gross domestic product of the applicant
country;
``(B) the burden of need, as determined by
estimated human morbidity and mortality and economic
impact related to pandemic influenza and the existing
capacity and resources of the applicant country to
control the spread of the disease; and
``(C) the willingness of the country to cooperate
with other countries with respect to preventing and
controlling the spread of the pandemic influenza; and
``(5) any other information the Secretary determines
necessary.
``(c) Use of Funds.--Funds from any Pandemic Fund established as
provided for in this section shall be used to complement and augment
ongoing bilateral programs and activities from the United States and
other donor nations, or establish new programs as needed.
``SEC. 2146. INTERNATIONAL DIPLOMATIC AND DEVELOPMENT STRATEGY.
``(a) Policy.--It is the policy of the United States to develop and
implement a comprehensive diplomatic strategy targeted at (but not
limited to) nations in Southeast and East Asia that are most at risk
for an outbreak of the avian influenza, including Cambodia, China,
Laos, Thailand, Indonesia, and Vietnam, in order to strengthen
international public health structures to detect, prevent, and
effectively respond to an outbreak of the avian flu.
``(b) Strategy.--The strategy developed and implemented under
subsection (a) shall include--
``(1) supporting information sharing and strengthening
surveillance, and rapid response capacities in key nations,
including the development of pandemic preparedness and response
plans;
``(2) issuing demarches to key nations in the region urging
additional cooperation and coordination with the United States,
regional governments, and international organizations;
``(3) provide for regular visits by cabinet-level officials
of the United States Government, including the Secretary of
State, Secretary of Health and Human Services, Secretary of
Agriculture, Secretary of Homeland Security, and Secretary of
Defense, to key nations in Southeast and East Asia in order to
enhance cooperation;
``(4) expanding ongoing technical assistance programs,
including training of personnel, procuring laboratory
equipment, logistics support, bio-safety procedures, quality
control, and case detection investigation techniques;
``(5) exchanges of scientists and medical personnel engaged
in significant work on issues related to avian flu;
``(6) encouraging regional governments to implement viable
compensation schemes to encourage reporting by poultry farmers
of cases of avian influenza in commercial flocks;
``(7) forward deployment of additional United States
Government science and medical personnel to embassies and
consulates in the region;
``(8) public awareness campaigns in the region, including
increased involvement of the Broadcasting Board of Governors
and Voice of America, to ensure timely and accurate
dissemination of information;
``(9) using the voice and vote of the United States at
meeting of appropriate international organizations to support
the aforementioned efforts; and
``(10) integrating the private sector, especially those
entities with a strong presence in the region, into this
effort.
``SEC. 2147. INTERNATIONAL PANDEMIC INFLUENZA ASSISTANCE.
``(a) In General.--The Secretary shall assist other countries in
preparation for, and response to, pandemic influenza, including
possible pandemic avian influenza.
``(b) International Surveillance.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, and
in collaboration with the Secretary of Agriculture, in
consultation with the World Health Organization and the World
Organization for Animal Health, shall establish minimum
standards for surveillance capacity for all countries with
respect to viral strains with pandemic potential, including
avian influenza.
``(2) Assistance.--The Secretary and the Secretary of
Agriculture shall assist other countries to meet the standards
established in paragraph (1) through--
``(A) the detail of officers to foreign countries
for the provision of technical assistance or training;
``(B) laboratory testing, including testing of
specimens for viral isolation or subtype analysis;
``(C) epidemiological analysis and investigation of
novel strains;
``(D) provision of equipment or supplies;
``(E) coordination of surveillance activities
within and among countries;
``(F) the establishment and maintenance of an
Internet database that is accessible to health
officials domestically and internationally, for the
purpose of reporting new cases or clusters of influenza
and other information that may help avert the pandemic
spread of influenza; and
``(G) other activities as determined necessary by
the Secretary.
``(c) Increased International Medical Capacity During Pandemic
Influenza.--Notwithstanding any other provision of law, the Secretary,
in consultation with the Secretary of State, may provide vaccines,
antiviral medications, and supplies to foreign countries from the
Strategic National Stockpile described under section 319F-2.
``(d) Assistance to Foreign Countries.--The Centers for Disease
Control and Prevention and the Health Resources and Services
Administration may provide assistance to foreign countries in carrying
out this section, which may include the detail of an officer to
approved international pandemic sites or the purchase of equipment and
supplies.
``SEC. 2148. PUBLIC EDUCATION AND AWARENESS CAMPAIGN.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention, in consultation with the United States Agency for
International Development, the World Health Organization, the World
Organization for Animal Health, and foreign countries, shall develop an
outreach campaign with respect to public education and awareness of
influenza and influenza preparedness.
``(b) Details of Campaign.--The campaign established under
subsection (a) shall--
``(1) be culturally and linguistically appropriate for
domestic populations;
``(2) be adaptable for use in foreign countries;
``(3) target high-risk populations (those most likely to
contract, transmit, and die from influenza);
``(4) promote personal influenza precautionary measures and
knowledge, and the need for general vaccination, as
appropriate; and
``(5) describe precautions at the State and local level
that could be implemented during pandemic influenza, including
quarantine and other measures.
``SEC. 2149. HEALTH PROFESSIONAL TRAINING.
``The Secretary, directly or through contract, and in consultation
with professional health and medical societies, shall develop and
disseminate pandemic influenza training curricula--
``(1) to educate and train health professionals, including
physicians, nurses, public health practitioners, virologists
and epidemiologists, veterinarians, mental health providers,
allied health professionals, and paramedics and other first
responders;
``(2) to educate and train volunteer, non-medical personnel
whose assistance may be required during a pandemic influenza
outbreak; and
``(3) that address prevention, including use of quarantine
and other isolation precautions, pandemic influenza diagnosis,
medical guidelines for use of antivirals and vaccines, and
professional requirements and responsibilities, as appropriate.
``SEC. 2150. RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH.
``The Director of the National Institutes of Health (referred to in
this section as the `Director of NIH'), in collaboration with the
Director of the Centers for Disease Control and Prevention, and other
relevant agencies, shall expand and intensify human and animal
research, with respect to influenza, on--
``(1) vaccine development and manufacture, including
strategies to increase immunological response;
``(2) effectiveness of inducing heterosubtypic immunity;
``(3) antigen-sparing studies;
``(4) antivirals, including minimal dose or course of
treatment and timing to achieve prophylactic or therapeutic
effect;
``(5) side effects and drug safety of vaccines and
antivirals in subpopulations;
``(6) alternative routes of delivery of vaccines,
antivirals, and other medications as appropriate;
``(7) more efficient methods for testing and determining
virus subtype;
``(8) protective measures;
``(9) modes of influenza transmission;
``(10) effectiveness of masks, hand-washing, and other non-
pharmaceutical measures in preventing transmission;
``(11) improved diagnostic tools for influenza; and
``(12) other areas determined appropriate by the Director
of NIH.
``SEC. 2151. RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``The Director of the Centers for Disease Control and Prevention,
in collaboration with other relevant agencies, shall expand and
intensify research, with respect to influenza, on--
``(1) historical research on prior pandemics to better
understand pandemic epidemiology, transmission, protective
measures, high-risk groups, and other lessons that may be
applicable to future pandemic;
``(2) communication strategies for the public during
pandemic influenza, taking into consideration age, racial and
ethnic background, health literacy, and risk status;
``(3) changing and influencing human behavior as it relates
to vaccination;
``(4) development and implementation of a public, non-
commercial and non-competitive broadcast system and person-to-
person networks;
``(5) population-based surveillance methods to estimate
influenza infection rates and rates of outpatient illness;
``(6) vaccine effectiveness;
``(7) systems to monitor vaccination coverage levels and
adverse events from vaccination; and
``(8) other areas determined appropriate by the Director of
the Centers for Disease Control and Prevention.
``SEC. 2152. INSTITUTE OF MEDICINE STUDY ON THE LEGAL, ETHICAL, AND
SOCIAL IMPLICATIONS OF PANDEMIC INFLUENZA.
``(a) In General.--The Secretary shall contract with the Institute
of Medicine to--
``(1) study the legal, ethical, and social implications of,
with respect to pandemic influenza--
``(A) animal/human interchange;
``(B) global surveillance;
``(C) case contact investigations;
``(D) vaccination and medical treatment;
``(E) community hygiene;
``(F) travel and border controls;
``(G) decreased social mixing and increased social
distance;
``(H) civil confinement; and
``(I) other topics as determined appropriate by the
Secretary; and
``(2) not later than 1 year after the date of enactment of
the Pandemic Preparedness and Response Act, submit to the
Secretary a report that describes recommendations based on the
study conducted under paragraph (1).
``(b) Implementation of Recommendations.--Not later than 90 days
after the submission of the report of under subsection (a)(2), the
Secretary shall address the recommendations of the Institute of
Medicine regarding the domestic and international allocation and
distribution of pandemic influenza vaccine and antivirals.
``SEC. 2153. NATIONAL PANDEMIC INFLUENZA ECONOMICS ADVISORY COMMITTEE.
``(a) In General.--There is established the National Pandemic
Influenza Economics Advisory Committee (referred to in this section as
the `Committee').
``(b) Membership.--
``(1) In general.--The members of the Committee shall be
appointed by the Comptroller General of the United States and
shall include domestic and international experts on pandemic
influenza, public health, veterinary science, commerce,
economics, finance, and international diplomacy.
``(2) Chair.--The Comptroller General of the United States
shall select a Chair from among the members of the Committee.
``(c) Duties.--The Committee shall study and make recommendations
to Congress and the Secretary on the financial and economic impact of
pandemic influenza and possible financial structures for domestic and
international pandemic response, relating to--
``(1) the development, storage, and distribution of
vaccines;
``(2) the development, storage, and distribution of
antiviral and other medications and supplies;
``(3) increased surveillance activities;
``(4) provision of preventive and medical care during
pandemic;
``(5) reimbursement for health providers and other core
public function employees;
``(6) reasonable compensation for farmers and other workers
that bear direct or disproportionate loss of revenue; and
``(7) other issues determined appropriate by the Chair.
``(d) Compensation.--
``(1) In general.--Each member of the Committee who is not
an officer or employee of the Federal Government shall be
compensated at a rate equal to the daily equivalent of the
annual rate of basic pay prescribed for level IV of the
Executive Schedule under section 5315 of title 5, United States
Code, for each day (including travel time) during which such
member is engaged in the performance of the duties of the
Committee. All members who are officers or employees of the
United States shall serve without compensation in addition to
that received for their services as officers or employees of
the United States.
``(2) Travel expenses.--A member of the Committee shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for an employee of an agency
under subchapter I of chapter 57 of title 5, United States
Code, while away from the home or regular place of business of
the member in the performance of the duties of the Committee.
``(e) Staff.--
``(1) In general.--The Chair of the Committee shall provide
the Committee with such professional and clerical staff, such
information, and the services of such consultants as may be
necessary to assist the Committee in carrying out the functions
under this section.
``(2) Detail of federal government employees.--
``(A) In general.--An employee of the Federal
Government may be detailed to the Committee without
reimbursement.
``(B) Civil service status.--The detail of the
employee shall be without interruption or loss of civil
service status or privilege.
``(3) Procurement of temporary and intermittent services.--
The Chair of the Committee may procure temporary and
intermittent services in accordance with section 3109(b) of
title 5, United States Code, at rates for individuals that do
not exceed the daily equivalent of the annual rate of basic pay
prescribed for level V of the Executive Schedule under section
5316 of that title.
``SEC. 2154. PANDEMIC INFLUENZA AND ANIMAL HEALTH.
``(a) In General.--The Secretary of Agriculture shall expand and
intensify efforts to prevent pandemic influenza, including possible
pandemic avian influenza.
``(b) Report.--Not later than 180 days after the date of enactment
this Act, the Secretary of Agriculture shall submit to Congress a
report that describes the anticipated impact of pandemic influenza on
the United States.
``(c) Assistance.--The Secretary of Agriculture, in consultation
with the Secretary of Health and Human Services, the World Health
Organization, and the World Organization for Animal Health, shall
provide domestic and international assistance with respect to pandemic
influenza preparedness to--
``(1) support the eradication of infectious animal diseases
and zoonosis;
``(2) increase transparency in animal disease states;
``(3) collect, analyze, and disseminate veterinary data;
``(4) strengthen international coordination and cooperation
in the control of animal diseases; and
``(5) promote the safety of world trade in animals and
animal products.
``(d) Electronic Database.--The Secretary of Agriculture, in
conjunction with the Secretary of Health and Human Services, shall
establish an electronic disease surveillance database in order to trace
the incidence of avian influenza in both animals and humans in the
United States.
``(e) Improvements in the National Animal Health Laboratory
Network.--The Secretary of Agriculture shall evaluate the National
Animal Health Laboratory Network and make recommendations for
improvements to participating laboratories and other State animal
health laboratories to rapidly diagnose and research avian influenza
outbreaks.
``(f) Communications Liaisons.--
``(1) In general.--The Secretary of Agriculture jointly
with the Secretary of Homeland Security shall designate a
liaison in each State to facilitate and coordinate
communications among and between States in the event of an
agriculture emergency.
``(2) Functions.--Each liaison designated under paragraph
(1) shall--
``(A) be the central point of contact for animal
health in communications with the Department of
Agriculture and the Department of Homeland Security;
``(B) communicate Federal preparedness and response
plans to State and local agriculture officials and
veterinarians; and
``(C) communicate concerns from State and local
agriculture officials and veterinarians to the
Department of Agriculture and Department of Homeland
Security and the Department of Health and Human
Services.
``Subtitle 4--Strengthening Public Health Immunization Capacity and
Supply
``SEC. 2161. FINDINGS.
``Congress finds that--
``(1) effective pandemic influenza preparedness and
response is dependent upon the existence of solid public health
infrastructure to combat seasonal flu;
``(2) the domestic surveillance and vaccine production and
distribution capabilities needed in a time of crisis should be
well established and active in a non-crisis capacity to enable
a more efficient response to pandemic influenza; and
``(3) each State receiving Federal funds should have a
State Immunization Program Coordinator, who should be
responsible for coordinating and implementing activities
related to influenza.
``SEC. 2162. VACCINE SUPPLY.
``(a) Requests for More Doses.--
``(1) In general.--Not later than March 15 of each year,
the Secretary shall enter into contracts with manufacturers to
produce such additional doses of the influenza vaccine as
determined necessary by the Secretary.
``(2) Content of contract.--A contract for additional doses
shall provide that the manufacturer will be compensated by the
Secretary at an equitable rate negotiated by the Secretary and
the manufacturer for any doses that--
``(A) were not sold by the manufacturer through
routine market mechanisms at the end of the influenza
season for that year; and
``(B) were requested by the Secretary to be
produced by such manufacturer.
``(3) When such vaccine purchases should take place.--The
Secretary may purchase from the manufacturer the doses for
which it has contracted at any time after which it is
determined by the Secretary, in consultation with the
manufacturer, that the doses will likely not be absorbed by the
private market.
``(b) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary.
``SEC. 2163. DISCONTINUANCE OF INFLUENZA VACCINE.
``(a) In General.--
``(1) Notice to secretary.--A manufacturer of the influenza
vaccine shall notify the Secretary of a discontinuance of the
manufacture of the vaccine at least 12 months prior to the date
of the discontinuance.
``(2) Director of centers for disease control and
prevention.--Promptly after receiving a notice under paragraph
(1), the Secretary shall inform the Director of the Centers for
Disease Control and Prevention of the notice. Promptly after
determining that a reduction under subsection (b) applies with
respect to such a notice, the Secretary shall inform such
Director of the reduction.
``(3) Relationship to separate notice program.--In the case
of influenza vaccine that is approved by the Secretary and is a
drug described in section 506C(a), this section applies to the
vaccine in lieu of section 506C.
``(b) Reduction in Notification Period.--The notification period
required under subsection (a) for a manufacturer may be reduced if the
manufacturer certifies to the Secretary that good cause exists for the
reduction, such as a situation in which--
``(1) a public health problem may result from continuation
of the manufacturing for the 12-month period;
``(2) a biomaterials shortage prevents the continuation of
the manufacturing for the 12-month period;
``(3) continuation of the manufacturing for the 12-month
period may cause substantial economic hardship for the
manufacturer;
``(4) the manufacturer has filed for bankruptcy under
chapter 7 or 11 of title 11, United States Code; or
``(5) the manufacturer can continue the distribution of the
vaccine involved for 12 months.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation of the
manufacture of influenza vaccines to appropriate physician and patient
organizations.
``SEC. 2164. SHORTAGE PREPAREDNESS AND RESPONSE.
``(a) Emergency Response Plans Regarding Shortages.--
``(1) National Emergency Response Plan.--The Secretary
shall develop and maintain a national plan for the response to
potential shortages in supplies of influenza vaccines that
would constitute public health emergencies. The plan shall
include provisions with respect to communication among relevant
entities, distribution of available supplies of the influenza
vaccine involved, the designation of populations to be given
priority for immunizations, interactions with State and local
governments, the use of the National Stockpile, and special
considerations for specific vaccines. The initial plan shall be
completed not later than 12 months after the date of the
enactment of this section.
``(2) State Emergency Response Plan.--Each State that
receives funds under this Act shall, not later than 6 months
after the date on which the National Plan is issued under
paragraph (1), develop, through the State Immunization
Coordinator, a State Emergency Response Plan that is modeled on
the National Plan.
``SEC. 2165. PROVISIONS TO INCREASE VACCINE COVERAGE RATES.
``(a) In General.--The Secretary shall develop a plan for the
distribution of seasonal flu vaccines to ensure that uninsured and
underinsured adults and children have access to annual influenza
vaccines and vaccines for conditions potentially exacerbated by
exposure to pandemic influenza. Immunizations should be available to
such populations as well as children in the VFC program through a wide
variety of providers including both Federally qualified health centers
and State and local health departments.
``(b) Requirement.--The Secretary shall--
``(1) conduct an assessment to determine the number of
adults in need of vaccinations and the barriers to vaccinating
adults; and
``(2) develop and implement strategies to increase the rate
of immunizations in populations in which a significant number
of individuals have not received immunizations with the
federally recommended vaccines (as defined in section 317A(g))
for the populations.
``(c) Definition.--For purposes of this section, the term `adult'
means an individual who is not a child as defined in section 1928 of
the Social Security Act.
``(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, such sums as may be necessary.
``SEC. 2166. OUTREACH, COMMUNICATION, EDUCATION.
``(a) Education Program Regarding Adult Immunizations.--The
Secretary, acting through the Director of the Centers for Disease
Control and Prevention (in this section referred to as the `Director'),
shall conduct a public awareness campaign and education and outreach
efforts each year during the time period preceding the influenza season
on each of the following:
``(1) The importance of receiving the influenza vaccine.
``(2) Which populations the Director recommends to receive
the influenza vaccine to prevent health complications
associated with influenza, including health care workers and
their household contacts.
``(3) Professional medical education of physicians, nurses,
pharmacists, and other health care providers and such
providers' associated organizations.
``(4) Information that emphasizes the safety and benefit of
recommended vaccines for the public good.
``(b) Outreach to Medicare Recipients.--
``(1) Program.--
``(A) In general.--The Director, in consultation
with the Administrator of the Centers for Medicare &
Medicaid Services, shall, at the earliest possible time
in the influenza vaccine planning and production
process, reach out to providers of medicare services,
including managed care providers, nursing homes,
hospitals, and physician offices to urge early and full
preordering of the influenza vaccine so that production
levels can accommodate the needs for the influenza
vaccine.
``(B) Rates of immunization among medicare
recipients.--The Director shall work with the
Administrator of the Centers for Medicare & Medicaid
Services to publish the rates of influenza immunization
among individuals receiving assistance under the
medicare program under title XVIII of the Social
Security Act (42 U.S.C. 1395 et seq.).
``(2) State and public health adult immunization
activities.--The Director shall support the development of
State adult immunization programs that place emphasis on
improving influenza vaccine delivery to high-risk populations
and the general population, including the exploration of
improving access to the influenza vaccine.
``(3) Existing modes of communication.--In carrying out the
public awareness campaign and education and outreach efforts
under paragraph (1) and (2), the Director may use existing
websites or structures for communication.
``(4) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each of fiscal years 2005 through 2009.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2006 through 2010.''.
SEC. 4. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN COMMERCE RELATED TO
TREATMENTS FOR PANDEMIC INFLUENZA.
Section 319F-3 of the Public Health Service Act (as added by
section __ and amended by section __(a)) is further amended by adding
at the end the following:
``(i) Unfair or Deceptive Acts or Practices in Commerce Related to
Treatments for Pandemic Influenza.--
``(1) Sales to consumers at unconscionable price.--
``(A) In general.--During any public health
emergency declared by the Secretary under section 319
related to pandemic influenza, it shall be unlawful for
any person to sell any drug (including an anti-viral
drug), device, or biologic for the prevention or
treatment of influenza in, or for use in, the area to
which that declaration applies at a price that--
``(i) is unconscionably excessive (as
determined by the Secretary); or
``(ii) indicates the seller is taking
unfair advantage of the circumstances to
increase prices unreasonably.
``(B) Factors to be considered.--In determining
whether a violation of paragraph (1) has occurred, a
court shall take into account, among other factors,
whether--
``(i) the amount charged represents a gross
disparity between the price of a drug, device,
or biologic for the prevention or treatment of
influenza and the price at which the drug,
device, or biologic was offered for sale in the
usual course of the seller's business
immediately prior to the public health
emergency; or
``(ii) the amount charged grossly exceeds
the price at which the same or similar drug,
device, or biologic for the prevention or
treatment of influenza was readily obtainable
by other purchasers in the area in which the
declaration applies.
``(C) Mitigating factors.--In determining whether a
violation of subparagraph (A) has occurred, the court
shall also take into account, among other factors, the
price that would reasonably equate supply and demand in
a competitive and freely functioning market and whether
the price at which the drug, device, or biologic for
the prevention or treatment of influenza was sold
reasonably reflects additional costs, not within the
control of the seller, that were paid or incurred by
the seller.
``(2) False pricing information.--It shall be unlawful for
any person to report information related to the wholesale price
of any drug, device, or biologic for the prevention or
treatment of influenza to the Secretary if--
``(A) that person knew, or reasonably should have
known, the information to be false or misleading;
``(B) the information was required by law to be
reported; and
``(C) the person intended the false or misleading
data to affect data compiled by the department or
agency involved for statistical or analytical purposes
with respect to the market for drugs, devices, or
biologics for the prevention or treatment of influenza.
``(3) Market manipulation.--It shall be unlawful for any
person, directly or indirectly, to use or employ, in connection
with the purchase or sale of drugs, devices, or biologics for
the prevention or treatment of influenza at wholesale, any
manipulative or deceptive device or contrivance, in
contravention of such rules and regulations as the Secretary
may prescribe as necessary or appropriate in the public
interest or for the protection of United States citizens.''.
SEC. 5. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as may be
necessary to carry out this Act (and the amendments made by this Act)
for each of the fiscal years 2006 through 2010.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S11133-11133)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11133-11138)
Sponsor introductory remarks on measure. (CR S13960)
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