II
110th CONGRESS
1st Session
S. 2456
IN THE SENATE OF THE UNITED STATES
December 12, 2007
Mr. Reid (for Mrs. Clinton (for herself and Mr. Roberts)) 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 to improve and secure an adequate supply of influenza vaccine.
Short title
This Act may be cited as
the Influenza Vaccine Security Act of
2007
.
Market Guarantees
Amendment 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:
Influenza vaccine security
Establishment of an influenza vaccine target and stockpile
Annual target
The Secretary, in
consultation with the Advisory Committee on Immunization Practices to the
Centers for Disease Control and Prevention (referred to in this subtitle as the
Advisory Committee
), shall determine an annual production target
for influenza vaccine, based on the recommendations of the Advisory Committee.
Based on such target, the Secretary, acting through the Centers for Disease
Control and Prevention, shall coordinate with the private market to encourage
the production of such vaccine in amounts that will meet the annual
target.
Stockpile
Prior to the start of each annual influenza
season (as determined by the Secretary), the Secretary is authorized to
purchase and store from multiple manufacturers an amount not to exceed 10
percent of the total amount of influenza vaccine, including one or more active
vaccine antigen ingredients in bulk or filled form, that is designated for
production by the Advisory Committee for placement in the strategic national
stockpile under section 121 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (referred to in this subtitle as the
strategic national stockpile
). Such vaccine shall be held in
reserve to be used in the event of a vaccine shortage in a given influenza
season. The Secretary shall coordinate with the manufacturers involved to
ensure that reserving amounts of vaccine for the stockpile does not interfere
with the early season delivery or early season administration of vaccine to
high priority populations (as defined by the Advisory Committee on Immunization
Practices and the Centers for Disease Control and Prevention) (referred to in
this subtitle as high priority populations
).
Vaccine buyback program
In general
The Secretary shall establish an influenza vaccine buyback protocol under which the Secretary may enter into buyback contracts with manufacturers of influenza vaccine to purchase such manufacturers' excess stocks of influenza vaccine so long as such vaccine has been manufactured in accordance with the recommendations of the Advisory Committee for the production of seasonal influenza vaccine.
Manufacturers
The Secretary shall have the discretion to award buyback contracts under subsection (a) to several influenza vaccine manufacturers in a manner consistent with the goal of providing stability in the influenza vaccine market, as long as the Federal Government purchases not more than 50 percent of the excess influenza vaccine stock of any single manufacturer at market price.
Cooperation with manufacturers, distributors, and wholesalers
As a condition of participation in the buyback program under this section, the Director of the Centers for Disease Control and Prevention shall work in cooperation with influenza vaccine manufacturers and wholesalers and distributors within the chain of custody from factory to health care institution or health care providers to share pertinent information that will allow for the tracking of influenza vaccine, maximize the delivery and availability of influenza vaccines to high priority populations, and ensure that influenza vaccine is delivered on an equitable basis, particularly in times of vaccine shortages.
Confidentiality
The information submitted to the Centers for Disease Control and Prevention or its contractors, if any, under subsections (c) and (d) shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18, United States Code, relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage over its competitors.
Ability To negotiate
The Secretary shall have the ability to negotiate, on a case-by-case basis, the submission of information under subsection (c), as long as the information provided will achieve the goals of tracking of the influenza vaccine, maximizing the delivery and availability of influenza vaccines to high priority populations, and ensuring that influenza vaccine is delivered on an equitable geographical basis, particularly in times of vaccine shortages.
Notice
In general
For purposes of maintaining and administering the supply of vaccines described under subsection (a), the Secretary shall by contract require that a manufacturer of a vaccine included in such supply provide not less than 12 months notice to the Secretary of a purposeful discontinuance of the manufacture of such vaccine by the manufacture of the vaccine.
Reduction of period of notice
The notification period required under paragraph (1) shall not apply in a case in which vaccine production is interrupted because of unforeseen manufacturing concerns.
Use of vaccine post buyback
Following the buyback of vaccine under this section, the Secretary shall direct that any vaccine purchased in such buyback be used for the following activities:
Use in late-season mass vaccination exercises conducted in coordination with Federal, State or local agencies engaged in emergency preparedness and bioterrorism preparedness activities. Such exercises should be carried out in partnership with voluntary organizations working to improve emergency preparedness and bioterrorism preparedness.
Promoting and carrying out late-season vaccination through the Indian Health Service, the Public Health Service, the Department of Veterans Affairs, or through other federally funded health care providers, such as community health centers and rural health clinics.
Other activities approved by the Secretary.
Critical supply purchase program
In general
The Secretary shall increase the amount of antiviral medications, N–95 respirator masks, and other protections and treatments, as determined necessary by the Secretary as they become available, to treat and prevent pandemic influenza, in the strategic national stockpile. In increasing such amounts, the Secretary shall consult with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary for Preparedness and Response, to determine the amounts that are necessary to provide adequate protection to not less than the number of individual who respond to an influenza epidemic.
Pediatric programs
The Secretary is encouraged to consult with all relevant Federal agencies and the private sector to develop and approve N–95 respirators and other protections and treatments, as determined necessary by the Secretary, to treat and prevent pandemic influenza, and shall ensure that such products are represented in adequate amounts in the strategic national stockpile to provide adequate protection to pediatric populations in the United States.
Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this subtitle in each of fiscal years 2008 through 2012.
.
Food and Drug Administration assistance to manufacturers
Amendment to the Food, Drug, and Cosmetic Act
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:
Provisions related to the emergency acquisition of vaccines
In general
Increased communication
The Food and Drug Administration shall carry out activities to increase communication between the agency and the scientific community regarding vaccine development and regulation, including participation in conferences on the science related to infectious diseases, influenza, biologic manufacturing, and other issues as determined appropriate by the Director of the Center for Biologics Evaluation and Research.
Regulatory roadmap
The Commissioner, in consultation with the Director of the Centers for Disease Control and Prevention, the Secretary, and other agencies or participants as determined appropriate by the Secretary, shall develop a regulatory roadmap to address the following issues surrounding emergency use authorization of influenza vaccine, as determined by the Secretary during a public health emergency involving an actual or imminent outbreak of naturally occurring or engineered seasonal influenza:
Policies for the emergency use authorization of influenza vaccine that is produced and sold in other countries so that such vaccine may be imported into the United States by the United States Government during a vaccine shortage.
Policies for the facilitation of the distribution of any such vaccine imported into the United States during a vaccine shortage, including the interstate transportation, allocation and equitable distribution of vaccine among high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) during an emergency use situation.
Policies for the communication and coordination of a response to an emergency use authorization with State and local health departments, including guidelines for notification of such entities in such situations.
Policies for the emergency use authorization of vaccines that are in clinical development in both the United States and other countries, including clarification of IND protocols for such vaccines, particularly those using new vaccine development technologies.
Consultation
In developing the roadmap under paragraph (2), the Commissioner shall solicit input from private and nonprofit stakeholders, including State and local health officials, and such input shall include recommendations for developing emergency use authorization guidelines that maintain the scientific and regulatory standards of the Food and Drug Administration.
Standing orders
Development
The Secretary shall direct the Centers for Disease Control and Prevention, in conjunction with State and local health departments and representatives of State medical boards and nursing examiners, to develop and publish a model standing order that will, at a minimum, address the need for standing orders to administer influenza vaccine in hospitals, community health centers, nursing homes, and other assisted living facilities, and by home health care providers. The Centers for Disease Control and Prevention is encouraged to expand such a model standing order to take into account—
the administration of other Medicare covered vaccines; and
the delivery of influenza vaccine to patients in children's hospitals or other institutions serving the long-term care needs of a pediatric population, including those in a non-clinical setting.
Implementation
Not less than 1 year after the publication of the standing order under paragraph (A), States shall be required to implement such standing order in order to be eligible to receive grants under this Act.
Rule of construction
Nothing in this paragraph shall be construed as precluding the application of State laws, so long as such laws do not restrict the implementation of this requirements of the Influenza Vaccine Security Act of 2007 (and the amendments made by such Act).
Authorization of appropriations
There are authorized to be appropriated to carry out this section, $5,000,000 for fiscal year 2008, and such sums as may be necessary for each of fiscal years 2009 through 2012, to be made available to the Food and Drug Administration to provide the technical assistance and take advantage of the training opportunities as designated in this section.
.
Vaccine education, outreach, and coordination
Authority of the National Center for Immunization and Respiratory Diseases for coordination, education, outreach, and communication across HHS
Section 2102 of the Public Health Service Act (42 U.S.C. 300aa–2) is amended—
in subsection (a), by adding at the end the following:
Coordination of support
The Director of the Center, in consultation with the Director of the National Institute for Allergy and Infectious Disease, shall—
coordinate efforts in regard to all influenza vaccine education, outreach, surveillance, and research activities within the Department in support of the goal of—
increasing overall influenza vaccination rates in the United States, particularly those of high priority populations (as defined by the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention) and health care providers;
increasing vaccination rates among medically underserved populations with low vaccination rates; and
any other vaccine promotion activities as directed by the Secretary;
coordinate educational efforts under this paragraph with the National Vaccine Program Office, State and local health departments, the National Institutes of Health, and all other relevant Federal and other entities as designated by the Director; and
provide an annual report to Congress on the progress being made toward the goals described in subparagraph (A).
; and
by adding at the end the following:
Appropriations for coordination of influenza vaccine outreach activities
There is authorized to be appropriated to carry out activities under subsection (a)(10), $2,000,000 for each of fiscal years 2008 through 2012.
.
Increased influenza vaccine and outbreak surveillance activities
Tracking network and demonstration grants
Title III of the Public Health Service Act is amended by inserting after section 319B (42 U.S.C. 247d–2) the following:
Tracking network and demonstration grants
Tracking system
Establishment
Not later than 2 years after the date of enactment of this section, the Director of the Centers for Disease Control and Prevention, in conjunction with State and local public health officials and health provider and nonprofit organizations, shall establish an electronic tracking system through which the Director and such officials can determine the amount of influenza vaccine within a 24-hour window that is available for distribution to patients, as well as the need for such vaccine on a county-by-county basis, and the progress of vaccine delivery and distribution efforts at the State and local level.
Estimates
The
tracking system established under paragraph (1) shall collect estimates of the
size of high priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and Prevention)
(referred to in this section as high priority populations
) in
each county in the United States, so as to better determine where influenza
vaccine resources may need to be directed in the case of an emergency.
Provision of information
To be eligible to participate in buyback programs the vaccine manufacturer shall provide information to the tracking system as the Director of the Centers for Disease Control and Prevention determines appropriate in accordance with subtitle 3 of title XXI.
Confidentiality
The information submitted to the Secretary (or a contractors, if any) under this section or under any other section of this Act related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18, United States Code, relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.
Guidelines
The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines permitting the Department of Health and Human Services to carry out paragraphs (1) and (2) and (3).
Expansion of current systems and activities
Surveillance system
Not later than 4 years after the date of enactment of this section, the Director of the Centers for Disease Control and Prevention shall upgrade and enhance the influenza surveillance system of the Centers for Disease Control and Prevention to report influenza data from State and local health departments into the tracking system established under subsection (a)(1).
Educational materials
The tracking system shall contain information to assist users in accessing influenza education, outreach, and communications tools, such as those developed and financed under the Influenza Vaccine Security Act of 2007 (and the amendments made by such Act).
Demonstration grants
In general
The Director of the Centers for Disease Control and Prevention shall award demonstration grants to State and local health departments to enable such departments to enter into contract with hospitals, community health centers, long-term care facilities, physicians’ offices, and health care facilities operated or funded by such departments to assist such department and entities in upgrading their information technology, infrastructure, and workforce in a manner that will allow such departments and entities to improve their ability to report and track influenza vaccine dissemination.
Priority
In awarding grants under paragraph (1), priority shall be given to departments and entities that serve high priority populations in medically underserved areas.
Authorization of appropriations
There are authorized to be appropriated—
to carry out subsection (a), $100,000,000 for each of fiscal years 2008 through 2012, of which $500,000 for each fiscal year shall be made available to implement subsection (b)(3); and
to carry out subsection (c), $100,000,000 for each of fiscal years 2008 through 2012.
.
Flu vaccine outreach and education
Educational efforts and grants
Title III of the Public Health Service Act is amended by inserting after section 319B–1 (as added by section 401) the following:
Immunization educational efforts and grants
In general
The Director of the Centers for Disease Control and Prevention, in conjunction with State and local health departments, shall revise and expand the influenza-related educational materials to the Centers for Disease Control and Prevention, and facilitate the use of such materials by health care providers and patients. The Director is authorized to coordinate such educational efforts with nonprofit provider and patient advocacy groups.
Influenza vaccine education and outreach
In general
In order to achieve
an optimal balance in the influenza vaccine market, and to ensure that the
recommendations of the Advisory Committee on Immunization Practices to the
Centers for Disease Control and Prevention for vaccine administration are
carried out to the maximum extent possible, the Director of the Centers for
Disease Control and Prevention, in conjunction with State and local health
departments, shall carry out influenza immunization education and outreach
activities that target physicians and other health care providers, health
insurance providers, health care institutions and patients, particularly those
in high priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and Prevention)
(referred to in this section as high priority
populations
).
Types of activities
The education and outreach activities under paragraph (1) shall include—
activities to encourage voluntary participation in influenza vaccination programs, with the goal of increasing overall influenza vaccination rates in the United States, achieving full influenza vaccination of all high priority populations, and full use of each season’s influenza vaccine supply and late season vaccination;
the provision of information on influenza prevention, including to medically underserved communities with low vaccination rates;
activities to increase the number of healthcare providers who receive influenza vaccines each year; and
other influenza educational efforts determined appropriate by the Director.
Grants
The Director of the Centers for Disease Control and Prevention may award grants to State and local health departments to carry out activities to encourage individuals, particularly those from high priority populations, to seek out influenza vaccinations.
Collaboration
State and local health departments that receive grants under subsection (b) are encouraged to collaborate on projects with physicians and other health care providers, health insurance providers, health care institutions, and groups representing high priority populations.
Authorization of appropriations
In addition to any amounts otherwise available through the Secretary for influenza outreach and education, there is authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2008 through 2012.
.