[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2456 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 2456

    To amend the Public Health Service Act to improve and secure an 
                 adequate supply of influenza vaccine.


_______________________________________________________________________


                   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.

    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 ``Influenza Vaccine Security Act of 
2007''.

                       TITLE I--MARKET GUARANTEES

SEC. 101. 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:

                ``Subtitle 3--Influenza Vaccine Security

``SEC. 2141. ESTABLISHMENT OF AN INFLUENZA VACCINE TARGET AND 
              STOCKPILE.

    ``(a) 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.
    ``(b) 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').

``SEC. 2142. VACCINE BUYBACK PROGRAM.

    ``(a) 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.
    ``(b) 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.
    ``(c) 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.
    ``(d) 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.
    ``(e) 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.
    ``(f) Notice.--
            ``(1) 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.
            ``(2) 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.
    ``(g) 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:
            ``(1) 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.
            ``(2) 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.
            ``(3) Other activities approved by the Secretary.

``SEC. 2143. CRITICAL SUPPLY PURCHASE PROGRAM.

    ``(a) 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.
    ``(b) 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.

``SEC. 2144. 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.''.

   TITLE II--FOOD AND DRUG ADMINISTRATION ASSISTANCE TO MANUFACTURERS

SEC. 201. 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:

``SEC. 909. PROVISIONS RELATED TO THE EMERGENCY ACQUISITION OF 
              VACCINES.

    ``(a) In General.--
            ``(1) 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.
            ``(2) 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:
                    ``(A) 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.
                    ``(B) 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.
                    ``(C) 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.
                    ``(D) 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.
            ``(3) 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.
            ``(4) Standing orders.--
                    ``(A) 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--
                            ``(i) the administration of other Medicare 
                        covered vaccines; and
                            ``(ii) 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.
                    ``(B) 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.
                    ``(C) 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).
    ``(b) 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.''.

        TITLE III--VACCINE EDUCATION, OUTREACH, AND COORDINATION

SEC. 301. 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--
            (1) in subsection (a), by adding at the end the following:
            ``(10) Coordination of support.--The Director of the 
        Center, in consultation with the Director of the National 
        Institute for Allergy and Infectious Disease, shall--
                    ``(A) coordinate efforts in regard to all influenza 
                vaccine education, outreach, surveillance, and research 
                activities within the Department in support of the goal 
                of--
                            ``(i) 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;
                            ``(ii) increasing vaccination rates among 
                        medically underserved populations with low 
                        vaccination rates; and
                            ``(iii) any other vaccine promotion 
                        activities as directed by the Secretary;
                    ``(B) 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
                    ``(C) provide an annual report to Congress on the 
                progress being made toward the goals described in 
                subparagraph (A).''; and
            (2) by adding at the end the following:
    ``(c) 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.''.

    TITLE IV--INCREASED INFLUENZA VACCINE AND OUTBREAK SURVEILLANCE 
                               ACTIVITIES

SEC. 401. 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:

``SEC. 319B-1. TRACKING NETWORK AND DEMONSTRATION GRANTS.

    ``(a) Tracking System.--
            ``(1) 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.
            ``(2) 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.
            ``(3) 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.
            ``(4) 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.
            ``(5) 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).
    ``(b) Expansion of Current Systems and Activities.--
            ``(1) 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).
            ``(2) 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).
    ``(c) Demonstration Grants.--
            ``(1) 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.
            ``(2) Priority.--In awarding grants under paragraph (1), 
        priority shall be given to departments and entities that serve 
        high priority populations in medically underserved areas.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) 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
            ``(2) to carry out subsection (c), $100,000,000 for each of 
        fiscal years 2008 through 2012.''.

              TITLE V--FLU VACCINE OUTREACH AND EDUCATION

SEC. 501. 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:

``SEC. 319B-2. IMMUNIZATION EDUCATIONAL EFFORTS AND GRANTS.

    ``(a) 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.
    ``(b) Influenza Vaccine Education and Outreach.--
            ``(1) 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').
            ``(2) Types of activities.--The education and outreach 
        activities under paragraph (1) shall include--
                    ``(A) 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;
                    ``(B) the provision of information on influenza 
                prevention, including to medically underserved 
                communities with low vaccination rates;
                    ``(C) activities to increase the number of 
                healthcare providers who receive influenza vaccines 
                each year; and
                    ``(D) other influenza educational efforts 
                determined appropriate by the Director.
    ``(c) 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.
    ``(d) 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.
    ``(e) 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.''.
                                 <all>