[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3502 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 3502

 To amend the Public Health Service Act with respect to immunizations 
  against vaccine-preventable diseases, including influenza, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2005

  Mr. Waxman (for himself, Mr. Brown of Ohio, and Ms. Roybal-Allard) 
 introduced the following bill; which was referred to the Committee on 
  Energy and Commerce, and in addition to the Committees on Ways and 
Means and Education and the Workforce, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act with respect to immunizations 
  against vaccine-preventable diseases, including influenza, 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 ``Vaccine Access and Supply Act''.

SEC. 2. CERTAIN AUTHORITIES REGARDING INFLUENZA AND OTHER VACCINES.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended--
            (1) by redesignating section 317A as section 317A-1; and
            (2) by inserting after section 317 the following section:

``SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLUENZA AND OTHER 
              VACCINES.

    ``(a) Purchase of Unsold Doses of Periodic-Change Vaccines.--
            ``(1) Producer-specific negotiation on supply for season.--
        In the case of influenza vaccine and each other periodic-change 
        vaccine, the Secretary shall, for each applicable vaccine 
        season, negotiate with each producer of the vaccine to reach an 
        agreement on the number of doses of the vaccine that the 
        producer will manufacture for such season. The Secretary is not 
        required under the preceding sentence to enter into such an 
        agreement with any producer.
            ``(2) Purchase of percentage of unsold doses.--With respect 
        to the number of doses of a periodic-change vaccine 
        manufactured for an applicable vaccine season by a producer in 
        accordance with an agreement under paragraph (1), the Secretary 
        shall purchase from the producer 50 percent of such doses that 
        are unsold for the season.
            ``(3) Price per dose.--
                    ``(A) Average sales price.--Subject to subparagraph 
                (B), the price per dose paid by the Secretary in a 
                purchase of periodic-change vaccine under paragraph (2) 
                shall be the average sales price for the vaccine for 
                the applicable vaccine season, as determined by the 
                Secretary.
                    ``(B) Audits; adjustments.--The Secretary may enter 
                into an agreement under paragraph (1) with a producer 
                regarding a periodic-change vaccine only if the 
                agreement includes a provision that permits the 
                Secretary to conduct audits of sales of such vaccine at 
                wholesale by the producer. The average sales price 
                determined under subparagraph (A) for a dose of the 
                vaccine for an applicable vaccine season shall be 
                adjusted by the Secretary as determined necessary by 
                the Secretary on the basis of such audits and on the 
                basis of any other information available to the 
                Secretary on sales of the vaccine at wholesale.
            ``(4) Definitions.--For purposes of this section:
                    ``(A) The term `periodic-change vaccine' means a 
                federally recommended vaccine (as defined in subsection 
                (g)) that is designed only for a single applicable 
                vaccine season due to characteristics of the etiologic 
                agent or agents for the disease involved, or due to 
                characteristics of the vaccine, that adversely affect 
                the extent to which the vaccine is safe and effective 
                after such season. Such term includes influenza 
                vaccine.
                    ``(B) The term `producer' means a person who--
                            ``(i) manufactures an approved vaccine (as 
                        defined in subsection (g)); or
                            ``(ii) who intends to manufacture such a 
                        vaccine and is determined by the Secretary to 
                        have the capacity to meet legal requirements 
                        applicable to such manufacturing.
                    ``(C)(i) The term `vaccine season', with respect to 
                a periodic-change vaccine, means a consecutive number 
                of months, not exceeding 24 months, during which the 
                Secretary recommends that the public in general, or 
                particular populations, as the case may be, receive 
                immunizations against the disease involved.
                    ``(ii) The term `applicable vaccine season', with 
                respect to a periodic-change vaccine, means the vaccine 
                season that is applicable to such vaccine.
            ``(5) Direct spending.--The requirement under paragraph (2) 
        that the Secretary make purchases of doses of periodic-change 
        vaccine constitutes budget authority in advance of 
        appropriations Acts, and represents the obligation of the 
        United States to make outlays for such purchases in accordance 
        with this subsection.
    ``(b) Immunization Program for Eligible Adults.--
            ``(1) In general.--The Secretary shall by regulation 
        establish a program for the distribution of qualified adult 
        vaccines through States with approved applications under 
        paragraph (4)(C), under which program--
                    ``(A) each vaccine-eligible adult, in receiving an 
                immunization with a qualified adult vaccine from a 
                program-registered provider on or after October 1, 
                2006, is entitled to receive the immunization without 
                charge for the cost of such vaccine; and
                    ``(B)(i) each program-registered provider who 
                administers such a vaccine to a vaccine-eligible adult 
                on or after such date is entitled to receive such 
                vaccine under the program without charge either for the 
                vaccine or its delivery to the provider; and
                    ``(ii) no vaccine is distributed under the program 
                to a provider unless the provider is a program-
                registered provider.
            ``(2) Relationship to program for distribution of pediatric 
        vaccines.--The provisions of the program under section 1928 of 
        the Social Security Act (including provisions taking effect on 
        or after the effective date of this section) apply with respect 
        to immunizations for vaccine-eligible adults under the program 
        under paragraph (1) to the same extent and in the same manner 
        as such provisions apply with respect to immunizations for 
        vaccine-eligible children under the program under such section 
        1928, except to the extent that such a provision conflicts with 
        this subsection. The preceding section may not be construed as 
        having any effect on the program under title XIX of the Social 
        Security Act, or as having the effect that, in the program 
        under paragraph (1), State plans comparable to State plans 
        under section 1902 of such Act are required.
            ``(3) Vaccine-eligible adult.--
                    ``(A) In general.--For purposes of this subsection, 
                the term `vaccine-eligible adult' means a federally 
                vaccine-eligible adult or a State vaccine-eligible 
                adult.
                    ``(B) Federally vaccine-eligible adult.--For 
                purposes of this subsection, the term `federally 
                vaccine-eligible adult' means each of the following:
                            ``(i) An adult who is not insured.
                            ``(ii) An adult who--
                                    ``(I) is administered a qualified 
                                adult vaccine by a Federally-qualified 
                                health center (as defined in section 
                                1905(l)(2)(B)) of the Social Security 
                                Act), by any other entity that is a 
                                covered entity under section 
                                340B(a)(4), or by any public clinic; 
                                and
                                    ``(II) is not insured with respect 
                                to the vaccine.
                            ``(iii) An adult who--
                                    ``(I) is administered a qualified 
                                adult vaccine while incarcerated in a 
                                Federal, State, or local penal or 
                                correctional institution, including an 
                                adult who is held pending judicial or 
                                administrative proceedings; and
                                    ``(II) is not insured with respect 
                                to the vaccine.
                    ``(C) State vaccine-eligible adult.--For purposes 
                of this subsection, the term `State vaccine-eligible 
                adult' means, with respect to a State and a qualified 
                adult vaccine, an adult who is within a class of adults 
                for which the State is purchasing the vaccine pursuant 
                to provisions that apply pursuant to paragraph (2).
            ``(4) Participation of states.--
                    ``(A) In general.--In the case or each State with 
                an approved application under subparagraph (C), the 
                Secretary shall provide, in accordance with provisions 
                that apply pursuant to paragraph (2), for the purchase 
                and delivery on behalf of the State, without charge to 
                the State, of such quantities of qualified adult 
                vaccines as may be necessary for the administration of 
                such vaccines to all vaccine-eligible adults in the 
                State on or after October 1, 2006.
                    ``(B) Program criteria.--The Secretary, in 
                accordance with provisions that apply pursuant to 
                paragraph (2), shall establish criteria for State 
                programs under paragraph (1).
                    ``(C) State application.--A State may participate 
                in the program under paragraph (1) only if the State 
                submits to the Secretary an application for such 
                participation. The Secretary shall approve any such 
                application that--
                            ``(i) is submitted in such form and such 
                        manner as the Secretary may require; and
                            ``(ii) demonstrates that the State is in 
                        compliance with criteria under subparagraph 
                        (B).
            ``(5) Additional definitions.--For purposes of this 
        subsection:
                    ``(A) The term `adult' means an individual who is 
                not a child as defined in section 1928 of the Social 
                Security Act.
                    ``(B) The term `adult vaccine' means a federally 
                recommended vaccine for adults.
                    ``(C)(i) The term `insured', with respect to an 
                adult, means that the adult is enrolled under, and 
                entitled to benefits under, a health insurance policy 
                or plan, including a group health plan, a prepaid 
                health plan, or an employee welfare benefit plan under 
                the Employee Retirement Income Security Act of 1974.
                    ``(ii) An adult is not insured with respect to a 
                qualified adult vaccine if the adult is entitled to 
                benefits under such a health insurance policy or plan, 
                but such benefits are not available with respect to the 
                cost of such vaccine.
                    ``(D) The term `qualified adult vaccine' means an 
                adult vaccine with respect to which a contract is in 
                effect pursuant to provisions that apply pursuant to 
                paragraph (2).
            ``(6) Direct spending.--The requirement under paragraph (1) 
        that the Secretary carry out a program constitutes budget 
        authority in advance of appropriations Acts, and represents the 
        obligation of the Federal Government to make outlays to provide 
        for immunizations of vaccine-eligible adults in accordance with 
        this subsection, including with respect to program-registered 
        providers and with respect to the purchase and delivery of 
        qualified adult vaccines on behalf of States.
    ``(c) Information on Location of Supplies of Vaccines; Emergency 
Authority of Secretary.--
            ``(1) In general.--If the Secretary publishes in the 
        Federal Register a declaration that there is a shortage of an 
        approved vaccine that constitutes a public health emergency, 
        each person who is a manufacturer or distributor of the vaccine 
        shall provide to the Secretary such information as the 
        Secretary may require with respect to the location of supplies 
        of the vaccine, including supplies in the possession of the 
        person, supplies scheduled to be received by the person, and 
        supplies sold by the person. Any such person who fails to 
        comply with an order of the Secretary under the preceding 
        sentence is liable to the United States for a civil penalty not 
        exceeding $1,000 for each day for which the person is in 
        violation of the order.
            ``(2) Availability to states.--Upon the request of a State, 
        the Secretary shall provide to the State the information 
        collected by the Secretary under paragraph (1) that relates to 
        the State.
    ``(d) Emergency Response Plan Regarding Shortages.--The Secretary 
shall develop and maintain a plan for the response of the Secretary to 
potential shortages in supplies of vaccines that would constitute 
public health emergencies. The plan shall include provisions with 
respect to communication among the relevant entities; distribution of 
available supplies of the vaccine involved; the designation of 
populations to be given priority for immunizations; interactions with 
State and local governments; use of the vaccine 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 
the Vaccine Access and Supply Act.
    ``(e) Research.--For the purpose of carrying out research toward 
the development of new vaccines for human use, including vaccines to 
prevent or control pandemic infections, there are authorized to be 
appropriated $250,000,000 for fiscal year 2006, and such sums as may be 
necessary for each of the fiscal years 2007 through 2010. Such 
authorization is in addition to any other authorizations of 
appropriations for such purpose.
    ``(f) Education Program Regarding Adult Immunizations.--
            ``(1) In general.--The Secretary shall develop and 
        implement a program to promote, among the adult population, 
        immunizations with federally recommended vaccines.
            ``(2) Content of program.--The program developed under 
        paragraph (1) shall include the use of a mass media campaign.
            ``(3) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each of the 
        fiscal years 2006 through 2010.
    ``(g) General Definitions.--For purposes of this section:
            ``(1) The term `approved vaccine' means a vaccine for which 
        a biologics license under section 351 is in effect.
            ``(2)(A) The term `federally recommended vaccine', with 
        respect to an adult, means an approved vaccine recommended by 
        the Advisory Committee on Immunization Practices (an advisory 
        committee established by the Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention).
            ``(B) The term `federally recommended vaccine', with 
        respect to a child, means a vaccine on the list referred to in 
        section 1928(e) of the Social Security Act.''.
    (b) Immunizations for Eligible Adults; Continued Coverage Under 
Group Health Plans.--With respect to the program under section 317A(b) 
of the Public Health Service Act (as added by subsection (a) of this 
section) (referred to in this subsection as the ``adult program''):
            (1) Pursuant to paragraph (2) of such section, the 
        provisions of section 1928 of the Social Security Act (referred 
        to in this section as the ``pediatric program'') that apply 
        with respect to the adult program include subsection (f) of the 
        pediatric program (relating to State maintenance of 
        immunization laws).
            (2) Section 609(d) of the Employee Retirement Income 
        Security Act, and the effective date for such section (under 
        section 4301(d) of Public Law 103-66), apply with respect to 
        the adult program to the same extent and in the same manner as 
        such section and effective date apply with respect to the 
        pediatric program. For purposes of such section 609(d) as 
        applied pursuant to the preceding sentence, the reference in 
        such section to May 1, 1993, shall be considered a reference to 
        July 1, 2005.
            (3) Section 4980B(f)(1) of the Internal Revenue Code of 
        1986 (as added by section 13422(a) of Public Law 103-66) 
        applies with respect to adult vaccines (as defined in the adult 
        program) to the same extent and in the same manner as such 
        section applies with respect to pediatric vaccines. For 
        purposes of such section 4980B(f)(1) as applied pursuant to the 
        preceding sentence, the reference in such section to May 1, 
        1993, shall be considered a reference to July 1, 2005. This 
        paragraph applies with respect to plan years beginning after 
        the date of the enactment of this Act.
            (4) Section 13631(d) of Public Law 103-66 (relating to 
        title XXII of the Public Health Service Act) applies with 
        respect to the adult program to the same extent and in the same 
        manner as such section applies with respect to the pediatric 
        program. For purposes of such section 13631(d) as applied 
        pursuant to the preceding sentence, the reference in such 
        section to May 1, 1993, shall be considered a reference to July 
        1, 2005.

SEC. 3. PROGRAM FOR DISTRIBUTION OF PEDIATRIC VACCINES.

    (a) Inclusion of All Public Clinics.--Section 1928(b)(2)(A)(iii)(I) 
of the Social Security Act (42 U.S.C. 1396s(b)(2)(A)(iii)(I)) is 
amended--
            (1) by striking ``or a rural health clinic'' and inserting 
        ``, a rural health clinic''; and
            (2) by inserting ``or a public clinic,'' after 
        ``1905(l)(1)),''.
    (b) Authority to Remove Certain Limitations on Payments to 
Manufacturers.--Section 1928(d)(3)(B) of the Social Security Act (42 
U.S.C. 1396s(d)(3)(B)) is amended by adding at the end the following: 
``In the case of a contract entered into on or after the date of the 
enactment of the Vaccine Access and Supply Act, the limitation 
established in the preceding sentence with respect to the price per 
dose of a pediatric vaccine does not apply if the Secretary determines 
that the limitation is having a significant adverse effect on the 
availability of sufficient supplies of the vaccine.''.
    (c) Sales From 6-Month Supply.--Section 1928(d)(6) of the Social 
Security Act (42 U.S.C. 1396s(d)(6)) is amended by inserting before the 
last sentence the following: ``The Secretary may sell such quantities 
of vaccines from such supply as the Secretary determines appropriate. 
Proceeds received from such sales shall be available to the Secretary 
only for the purposes of procuring pediatric vaccine stockpiles under 
this section and shall remain available until expended.''.

SEC. 4. AMENDMENTS TO PROGRAM OF VACCINE-RELATED GRANTS TO STATES.

    Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)) 
is amended by adding at the end the following paragraph:
    ``(3)(A)(i) For fiscal year 2006, the Secretary shall make grants 
described in paragraphs (1) and (2) (relating to immunizing individuals 
without charge) in an aggregate amount not exceeding $515,536,000.
    ``(ii) Of the amount available under subparagraph (A) for fiscal 
year 2006, the Secretary shall reserve not less than $80,000,000 for 
the purpose of providing immunizations for adults who have not, prior 
to fiscal year 2006, been served by immunization programs carried out 
with grants made pursuant to paragraph (1) or (2).
    ``(B)(i) For fiscal year 2007 and each subsequent fiscal year, the 
Secretary shall make grants described in paragraphs (1) and (2) in an 
aggregate amount equal to the sum of the amounts determined under 
subclauses (I) and (II), as follows:
            ``(I) Of the aggregate amount provided in such grants for 
        fiscal year 2006, the Secretary shall determine the portion 
        that was obligated to purchase vaccines. The amount determined 
        under this subclause is such portion as increased to offset the 
        percentage increase in the average sales price for such 
        vaccines for the most recent five-year period for which data 
        are available, taking into account reports under subparagraph 
        (F) (in the case of fiscal year 2007 and subsequent fiscal 
        years).
            ``(II) Of the aggregate amount provided in such grants for 
        fiscal year 2006, the Secretary shall determine the portion 
        that was obligated for purposes other than the purchase of 
        vaccines. The amount determined under this subclause is such 
        portion as increased to offset the percentage increase in the 
        Consumer Price Index for all urban consumers (all items; United 
        States city average) for the most recent five-year period for 
        which data are available.
    ``(ii) Of the amount available under clause (i) for a fiscal year, 
the Secretary shall, for the purpose described in subparagraph (A)(ii), 
reserve not less than the amount specified in such subparagraph as 
increased in accordance with the same methodology as applies under 
clause (i).
    ``(C) Subject to subparagraphs (D) through (F)), grants made 
pursuant to this paragraph shall be made in accordance with criteria of 
the Secretary issued under paragraphs (1) and (2) for immunization 
programs. The preceding sentence may not be construed as terminating 
the authority of the Secretary to modify such criteria.
    ``(D) The purposes for which grants made pursuant to this paragraph 
may be expended by a State or political subdivision include the 
following:
            ``(i) Conducting assessments to determine the number of 
        adults in the area involved who need immunizations and the 
        barriers to providing immunizations to such adults.
            ``(ii) Developing and implementing 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.
            ``(iii) Educating care givers, health care professionals, 
        and the public about the need to be immunized.
            ``(iv) Consulting with health care providers with respect 
        to ensuring proper and timely immunizations for their patients.
            ``(v) Investigating and responding to outbreaks of vaccine-
        preventable diseases.
            ``(vi) Developing and modifying plans to respond to 
        potential shortages in supplies of vaccines.
            ``(vii) Preparing reports under subparagraph (F) and any 
        additional reports that are submitted to the Secretary pursuant 
        to this paragraph.
    ``(E) A condition for the receipt by a State of a grant made 
pursuant to this paragraph for a fiscal year is that the State have (or 
agree to develop, in the case of a grant for fiscal year 2006) a State 
plan that--
            ``(i) ensures the distribution and administration of 
        vaccines in the event that the Secretary declares a shortage of 
        approved vaccines as a public health emergency; and
            ``(ii) includes plans for communication and coordination 
        between--
                    ``(I) State and local public health departments;
                    ``(II) community health centers;
                    ``(III) hospitals;
                    ``(IV) private physicians licensed within the 
                State; and
                    ``(V) to the extent practicable, vaccine 
                manufacturers and suppliers.
    ``(F) A condition for the receipt of a grant made pursuant to this 
paragraph for a fiscal year is that the applicant involved agree to 
submit to the Secretary a report that specifies for such year the 
quantity of each type of vaccine purchased with the grant and the per-
dose cost of the vaccine.
    ``(G) The requirements under subparagraphs (A) and (B) that the 
Secretary make grants constitutes budget authority in advance of 
appropriations Acts, and represents the obligation of the Federal 
Government to make outlays to provide for immunizations without charge 
pursuant to the grants in accordance with this paragraph.''.

SEC. 5. ONE-YEAR NOTICE ON DISCONTINUING MANUFACTURE OF VACCINE.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506C 
the following section:

``SEC. 506D. DISCONTINUANCE OF VACCINE.

    ``(a) In General.--
            ``(1) Notice to secretary.--A manufacturer of a vaccine 
        approved by the Secretary 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 a 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) a liability problem may exist for the manufacturer if 
        the manufacturing is continued for the 12-month period;
            ``(4) continuation of the manufacturing for the 12-month 
        period may cause substantial economic hardship for the 
        manufacturer;
            ``(5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code; or
            ``(6) 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 vaccines to appropriate physician and patient 
organizations.''.

SEC. 6. PROGRAM FOR PEDIATRIC VACCINE STOCKPILE; PARTICIPATION OF 
              MANUFACTURERS OF VACCINES.

    (a) In General.--Not later than 30 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services, in 
consultation with the Chairman of the Securities and Exchange 
Commission, shall submit to the Congress a plan to facilitate the 
participation of manufacturers of pediatric vaccines in the program 
operated by the Secretary to maintain a six-month supply of such 
vaccines (commonly referred to as the pediatric vaccine stockpile). 
With respect to the purchase of pediatric vaccines for such program, 
the plan shall include, as necessary, provisions for the accounting-
rules treatment of amounts paid by the Secretary to such manufacturers 
that will permit the manufacturers to treat the amounts as revenue upon 
receipt of the amounts.
    (b) Definition.--For purposes of subsection (a), the term 
``pediatric vaccine'' means a vaccine on the list referred to in 
section 1928(e) of the Social Security Act.

SEC. 7. PROHIBITION ON MEDICAID COST-SHARING FOR VACCINES RECOMMENDED 
              BY ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.

    (a) In General.--Section 1916 of the Social Security Act (42 U.S.C. 
1396o) is amended by adding at the end the following:
    ``(h) The State plan shall require that no provider participating 
under the State plan may impose a copayment, cost sharing charge, or 
similar charge for administering to an adult individual who is eligible 
for medical assistance under such plan a vaccine that is included on 
the recommended vaccine schedule for adults that is established (and 
periodically reviewed and appropriately revised) by the Advisory 
Committee on Immunization Practices of the Centers for Disease Control 
and Prevention and that is otherwise covered under the State plan.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect on October 1, 2005.
                                 <all>