Generic Prescription Drug Fairness Act of 2005 - Amends title XIX (Medicaid) of the Social Security Act to revise requirements for drug manufacturer reports to the Secretary of Health and Human Services on the average manufacturer price for each covered outpatient drug and the manufacturer's best price for single source and innovator multiple source drugs. Requires manufacturers to report also on the manufacturer's best price for each authorized generic drug and any other drugs sold under a new drug application approved under the Federal Food, Drug, and Cosmetic Act.
Applies the basic rebate for single source and innovator multiple source drugs to authorized generic drugs and any other drugs sold under an approved new drug application.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1903 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 1903
To amend title XIX of the Social Security Act to require drug
manufacturers to report the average manufacturer price and the best
price of authorized generic drugs and any other drugs sold under a new
drug application approved under section 505(c) of the Federal Food,
Drug, and Cosmetic Act to the Secretary of Health and Human Services.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 20, 2005
Mr. Rockefeller (for himself, Mr. Specter, Mr. Schumer, and Mr. McCain)
introduced the following bill; which was read twice and referred to the
Committee on Finance
_______________________________________________________________________
A BILL
To amend title XIX of the Social Security Act to require drug
manufacturers to report the average manufacturer price and the best
price of authorized generic drugs and any other drugs sold under a new
drug application approved under section 505(c) of the Federal Food,
Drug, and Cosmetic Act to the Secretary of Health and Human Services.
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 ``Generic Prescription Drug Fairness
Act of 2005''.
SEC. 2. IMPROVED REGULATION OF AUTHORIZED GENERIC DRUGS AND OTHER DRUGS
SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION
505(C) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Inclusion With Other Reported Average Manufacturer and Best
Prices.--Section 1927(b)(3)(A) (42 U.S.C. 1396r-8(b)(3)(A)) is
amended--
(1) by striking clause (i) and inserting the following:
``(i) not later than 30 days after the last
day of each rebate period under the agreement--
``(I) on the average manufacturer
price (as defined in subsection (k)(1))
for each covered outpatient drug for
the rebate period under the agreement
(including for each such drug that is
an authorized generic drug or is any
other drug sold under a new drug
application approved under section
505(c) of the Federal Food, Drug, and
Cosmetic Act); and
``(II) for each single source drug,
innovator multiple source drug,
authorized generic drug, and any other
drug sold under a new drug application
approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act,
on the manufacturer's best price (as
defined in subsection (c)(1)(C)) for
such drug for the rebate period under
the agreement;''; and
(2) in clause (ii), by inserting ``(including for such
drugs that are authorized generic drugs or are any other drugs
sold under a new drug application approved under section 505(c)
of the Federal Food, Drug, and Cosmetic Act)'' after ``drugs''.
(b) Conforming Amendments.--Section 1927 of such Act (42 U.S.C.
1396r-8) is amended--
(1) in subsection (c)(1)(C)--
(A) in clause (i), in the matter preceding
subclause (I), by striking ``or innovator multiple
source drug of a manufacturer'' and inserting ``,
innovator multiple source drug, or authorized generic
drug of a manufacturer, or any other drug of a
manufacturer that is sold under a new drug application
approved under section 505(c) of the Federal Food,
Drug, and Cosmetic Act''; and
(B) in clause (ii)--
(i) in subclause (II), by striking ``and''
at the end;
(ii) in subclause (III), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following:
``(IV) in the case of a
manufacturer that approves, allows, or
otherwise permits an authorized generic
drug or any other drug of the
manufacturer to be sold under a new
drug application approved under section
505(c) of the Federal Food, Drug, and
Cosmetic Act, shall be inclusive of the
lowest price for such authorized
generic or other drug available from
the manufacturer during the rebate
period to any wholesaler, retailer,
provider, health maintenance
organization, nonprofit entity, or
governmental entity within the United
States, excluding those prices
described in subclauses (I) through
(IV) of clause (i).''; and
(2) in subsection (k)--
(A) in paragraph (1)--
(i) by striking ``The term'' and inserting
the following:
``(A) In general.--The term''; and
(ii) by adding at the end the following:
``(B) Inclusion of authorized generic drugs.--In
the case of a manufacturer that approves, allows, or
otherwise permits an authorized generic drug or any
other drug of the manufacturer to be sold under a new
drug application approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act, such term shall
be inclusive of the average price paid for such
authorized generic or other drug by wholesalers for
drugs distributed to the retail pharmacy class of
trade, after deducting customary prompt pay
discounts.''; and
(B) by adding at the end the following:
``(10) Authorized generic drug.--The term `authorized
generic drug' means a listed drug (as that term is used in
section 505(j) of the Federal Food, Drug, and Cosmetic Act
that--
``(A) has been approved under section 505(c) of
such Act; and
``(B) is marketed, sold, or distributed directly or
indirectly to retail class of trade under a different
labeling, packaging (other than repackaging as the
listed drug in blister packs, unit doses, or similar
packaging for use in institutions), product code,
labeler code, trade name, or trade mark than the listed
drug.''.
(c) Effective Date.--The amendments made by this section take
effect on October 1, 2005.
SEC. 3. APPLICATION OF BASIC REBATE FOR SINGLE SOURCE AND INNOVATOR
MULTIPLE SOURCE DRUGS.
(a) In General.--Section 1927(c)(1) of the Social Security Act (42
U.S.C. 1396r-8(c)(1)) is amended--
(1) in subparagraph (A), in the matter preceding clause
(i), by striking ``or an innovator multiple source drug'' and
inserting ``, an innovator multiple source drug, or an
authorized generic drug or any other drugs sold under a new
drug application approved under section 505(c) of the Federal
Food, Drug, and Cosmetic Act''; and
(2) in subparagraph (C)(i), by striking ``or innovator
multiple source drug'' and inserting ``, an innovator multiple
source drug, or an authorized generic drug or any other drugs
sold under a new drug application approved under section 505(c)
of the Federal Food, Drug, and Cosmetic Act''.
(b) Effective Date.--The amendments made by subsection (a) shall
take effect on the date of enactment of this Act and shall apply to
rebate agreements entered into or renewed on or after that date.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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