S. 501Senate111th Congress (2009-2011)In Committee

Fair Prescription Drug Competition Act

Introduced February 26, 2009

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

February 26, 2009

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SenateIntro Referral

Introduced in Senate

February 26, 2009

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S2569-2570)

February 26, 2009

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

February 26, 2009

Floor Debate

13 members

What members said about S. 501 on the floor

3 Republicans9 Democrats1 Independent
Richard Burr
Sen. Richard BurrR-NC · Feb 26, 2009

Mr. President, I rise today in support of S. 485, the Select Agent Program and Biosafety Improvement Act of 2009. Today, I reintroduced this important legislation with my friend Senator Ted Kennedy.…

Arlen Specter
Sen. Arlen SpecterD-PA · Feb 26, 2009

Mr. President, I rise to introduce--the ``Stem Cell Research Enhancement Act similar to legislation that I have sponsored in the last two Congresses with Senators Harkin, Hatch, Kennedy, Feinstein,…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Feb 26, 2009

As we prepare to tackle the many challenges of our health care system, let's take the time to make sure that nursing schools are in a position to teach and train a new generation of nurses and nurse…

Bernard Sanders
Sen. Bernard SandersI-VT · Feb 26, 2009

Madam President, I think everybody recognizes that our current health care system is in very serious crisis. We have 46 million Americans who lack any health insurance. We have even more than that…

Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Feb 26, 2009

Mr. President, I rise today to introduce the Justice Integrity Act of 2009. I am pleased that Senator Specter, the ranking member of the Judiciary Committee, has joined me as an original cosponsor of…

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John D. Rockefeller IV
Sen. John D. Rockefeller IVD-WV · Feb 26, 2009

Mr. President, I rise today with Senators Schumer, Kohl, Leahy, and Brown to reintroduce an important piece of legislation, the Fair Prescription Drug Competition Act. Our legislation eliminates one…

John D. Rockefeller IV
Sen. John D. Rockefeller IVD-WV · Feb 26, 2009

Mr. President, I rise today with Senators Schumer, Kohl, Leahy, and Brown to reintroduce an important piece of legislation, the Fair Prescription Drug Competition Act. Our legislation eliminates one…

Tom Harkin
Sen. Tom HarkinD-IA · Feb 26, 2009

Mr. President, I have spoken many times in this Chamber about the promise of stem cell research. For more than a decade, ever since scientists first succeeded in deriving human embryonic stem cells,…

Jim Webb
Sen. Jim WebbD-VA · Feb 26, 2009

Mr. President, today I rise to introduce the bipartisan Federal and Military Retiree Health Care Equity Act. I introduce this bill with Senators Burr, Collins, Cardin, Durbin, Warner, Rockefeller,…

Ron Wyden
Sen. Ron WydenD-OR · Feb 26, 2009

Mr. President, I rise this afternoon to reintroduce the Withdraw Energy Addicting New Subsidies Act. I first introduced this legislation in the 109th Congress to repeal what I believed to be a…

Tom Coburn
Sen. Tom CoburnR-OK · Nov 18, 2010

Mr. President, I submit the following notice in writing: In accordance with rule V of the Standing Rules of the Senate, I hereby give notice in writing that it is my intention to move to suspend rule…

Mike  Johanns
Sen. Mike Johanns R-NE · Nov 18, 2010

Mr. President, in accordance with rule V of the Standing rules of the Senate, I hereby give notice in writing that it is my intention to move to suspend rule XXII, including any germaneness…

Harry Reid
Sen. Harry ReidD-NV · Nov 18, 2010

Mr. President, I submit the following notice in writing: In accordance with rule V of the Standing rules of the Senate, I hereby give notice in writing that it is my intention to move to suspend rule…

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Max Baucus
Sen. Max BaucusD-MT · Nov 18, 2010

Mr. President, I submit the following notice in writing: In accordance with rule V of the Standing rules of the Senate, I hereby give notice in writing that it is my intention to move to suspend rule…

Bill Text

Latest available legislative text

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Introduced in SenateIssued February 26, 2009

II

111th CONGRESS

1st Session

S. 501

IN THE SENATE OF THE UNITED STATES

February 26, 2009

Mr. Rockefeller (for himself, Mr. Schumer, Mr. Kohl, Mr. Leahy, Mr. Brown, and Mr. Inouye) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

1.

Short title

This Act may be cited as the Fair Prescription Drug Competition Act.

2.

Prohibition of authorized generics

(a)

In general

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

(w)

Prohibition of authorized generic drugs

(1)

In general

Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, direct or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.

(2)

Authorized generic drug

For purposes of this subsection, the term authorized generic drug—

(A)

means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; and

(B)

does not include any drug to be marketed, sold, or distributed—

(i)

by an entity eligible for exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or

(ii)

after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).

.

(b)

Conforming amendment

Section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(t)(3)) is amended by striking In this section and inserting In this subsection.