H.R. 1432House110th Congress (2007-2009)In Committee

Preserve Access to Affordable Generics Act

Introduced March 9, 2007

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Commerce, Trade and Consumer Protection.

March 12, 2007

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HouseIntro Referral

Introduced in House

March 9, 2007

HouseIntro Referral

Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.

March 9, 2007

HouseCommittee

Referred to the Subcommittee on Commerce, Trade and Consumer Protection.

March 12, 2007

Floor Debate

6 members

What members said about H.R. 1432 on the floor

4 Republicans2 Democrats
Jim McDermott
Rep. Jim McDermottD-WA-7 · Sep 17, 2008

Madam Speaker, I move to suspend the rules and agree to the resolution (H. Res. 1432) supporting the goals and ideals of National Adoption Day and National Adoption Month by promoting national…

Virginia Foxx
Rep. Virginia FoxxR-NC-5 · Sep 17, 2008

I thank my colleague from Illinois for yielding this time. I certainly am in very, very strong support of this resolution. I think that it is very important that we pass this bill, goals and ideals…

Phil Gingrey
Rep. Phil GingreyR-GA-11 · Sep 17, 2008

Madam Speaker, I thank the gentleman from Illinois for yielding. As a proud member of the Congressional Coalition on Adoption, I rise in strong support of H. Res. 1432. This important resolution…

Jon C. Porter
Rep. Jon C. PorterR-NV-3 · Sep 17, 2008

Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include therein extraneous materials on the bill under consideration. Madam…

Sheila Jackson Lee
Rep. Sheila Jackson LeeD-TX-18 · Sep 17, 2008

Madam Speaker, I stand here today in support of H.R. 1432, ``Supporting the Goals and Ideals of National Adoption Day and National Adoption Month by Promoting National Awareness of Adoption and the…

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Jerry Weller
Rep. Jerry WellerR-IL-11 · Sep 17, 2008

Madam Speaker, taking the lead of my chairman, I will close on this important resolution, but before I move to that, I have two speakers on our side who want to address this resolution which has been…

Bill Text

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Introduced in HouseIssued March 9, 2007

I

110th CONGRESS

1st Session

H. R. 1432

IN THE HOUSE OF REPRESENTATIVES

March 9, 2007

Mr. Waxman introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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 prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

1.

Short title

This Act may be cited as the Preserve Access to Affordable Generics Act.

2.

Congressional findings and declaration of purposes

(a)

Findings

The Congress finds that—

(1)

prescription drugs make up 11 percent of the national health care spending but are 1 of the largest and fastest growing health care expenditures;

(2)

56 percent of all prescriptions dispensed in the United States are generic drugs, yet they account for only 13 percent of all expenditures;

(3)

generic drugs, on average, cost 63 percent less than their brand-name counterparts;

(4)

consumers and the health care system would benefit from free and open competition in the pharmaceutical market and the removal of obstacles to the introduction of generic drugs;

(5)

full and free competition in the pharmaceutical industry, and the full enforcement of antitrust law to prevent anticompetitive practices in this industry, will lead to lower prices, greater innovation, and inure to the general benefit of consumers;

(6)

the Federal Trade Commission has determined that some brand name pharmaceutical manufacturers collude with generic drug manufacturers to delay the marketing of competing, low-cost, generic drugs;

(7)

collusion by the brand name pharmaceutical manufacturers is contrary to free competition, to the interests of consumers, and to the principles underlying antitrust law;

(8)

in 2005, 2 appellate court decisions reversed the Federal Trade Commission’s long-standing position, and upheld settlements that include pay-offs by brand name pharmaceutical manufacturers to generic manufacturers designed to keep generic competition off the market;

(9)

in the 6 months following the March 2005 court decisions, the Federal Trade Commission found there were three settlement agreements in which the generic received compensation and agreed to a restriction on its ability to market the product;

(10)

the Federal Trade Commission found that more than 2/3 of the approximately ten settlement agreements made in 2006 include a pay-off from the brand in exchange for a promise by the generic company to delay entry into the market; and

(11)

settlements which include a payment from a brand name manufacturer to a generic manufacturer to delay entry by generic drugs are anti-competitive and contrary to the interests of consumers.

(b)

Purposes

The purposes of this Act are—

(1)

to enhance competition in the pharmaceutical market by prohibiting anticompetitive agreements and collusion between brand name and generic drug manufacturers intended to keep generic drugs off the market;

(2)

to support the purpose and intent of antitrust law by prohibiting anticompetitive agreements and collusion in the pharmaceutical industry; and

(3)

to clarify the law to prohibit payments from brand name to generic drug manufacturers with the purpose to prevent or delay the entry of competition from generic drugs.

3.

Unlawful compensation for delay

The Clayton Act (15 U.S.C. 12 et seq.) is amended—

(1)

by redesignating section 28 as section 29; and

(2)

by inserting after section 27 the following:

28.

Unlawful interference with generic marketing

(a)

It shall be unlawful under this Act for any person, in connection with the sale of a drug product, to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim which—

(1)

an ANDA filer receives anything of value; and

(2)

the ANDA filer agrees not to research, develop, manufacture, market, or sell the ANDA product for any period of time.

(b)

Nothing in this section shall prohibit a resolution or settlement of patent infringement claim in which the value paid by the NDA holder to the ANDA filer as a part of the resolution or settlement of the patent infringement claim includes no more than the right to market the ANDA product prior to the expiration of the patent that is the basis for the patent infringement claim.

(c)

In this section:

(1)

The term agreement means anything that would constitute an agreement under section 1 of the Sherman Act (15 U.S.C. 1) or section 5 of the Federal Trade Commission Act (15 U.S.C. 45).

(2)

The term agreement resolving or settling a patent infringement claim includes, any agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim.

(3)

The term ANDA means an abbreviated new drug application, as defined under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

(4)

The term ANDA filer means a party who has filed an ANDA with the Federal Drug Administration.

(5)

The term ANDA product means the product to be manufactured under the ANDA that is the subject of the patent infringement claim.

(6)

The term drug product means a finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with 1 or more other ingredients, as defined in section 314.3(b) of title 21, Code of Federal Regulations.

(7)

The term NDA means a new drug application, as defined under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).

(8)

The term NDA holder means—

(A)

the party that received FDA approval to market a drug product pursuant to an NDA;

(B)

a party owning or controlling enforcement of the patent listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the FDA Orange Book) in connection with the NDA; or

(C)

the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any of the entities described in subclauses (i) and (ii) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities.

(9)

The term patent infringement means infringement of any patent or of any filed patent application, extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition and extensions thereof.

(10)

The term patent infringement claim means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court of law, that its ANDA or ANDA product may infringe any patent held by, or exclusively licensed to, the NDA holder of the drug product.

.

4.

Notice and certification of agreements

(a)

Notice of all agreements

Section 1112(c)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 3155 note) is amended by—

(1)

striking the Commission the and inserting the Commission (1) the; and

(2)

inserting before the period at the end the following: ; and (2) a description of the subject matter of any other agreement the parties enter into within 30 days of an entering into an agreement covered by subsection (a) or (b).

(b)

Certification of agreements

Section 1112 of such Act is amended by adding at the end the following:

(d)

Certification

The Chief Executive Officer or the company official responsible for negotiating any agreement required to be filed under subsection (a), (b), or (c) shall execute and file with the Assistant Attorney General and the Commission a certification as follows: I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing..

.

5.

Forfeiture of 180-day exclusivity period

Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting section 28 of the Clayton Act or after that the agreement has violated.

6.

Authorization of appropriations

There are authorized to be appropriated to the Federal Trade Commission such sums as may be necessary to carry out the provisions of this Act.