S. 438Senate110th Congress (2007-2009)In Committee

Fair Prescription Drug Competition Act

Introduced January 30, 2007

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. (text of measure as introduced: CR S1352)

January 30, 2007

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SenateIntro Referral

Introduced in Senate

January 30, 2007

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S1351-1352)

January 30, 2007

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1352)

January 30, 2007

Floor Debate

9 members

What members said about S. 438 on the floor

3 Republicans6 Democrats
Russell D. Feingold
Sen. Russell D. FeingoldD-WI · Jan 30, 2007

Mr. President, today I am reintroducing the Affordable Housing Expansion and Public Safety Act to address some of the housing affordability issues faced by my constituents and by Americans around the…

Barack Obama
Sen. Barack ObamaD-IL · Jan 30, 2007

Mr. President, there are countless reasons that the American people have lost confidence in the President's Iraq policy, but chief among them has been the Administration's insistence on making…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Jan 30, 2007

Mr. President, today I introduce legislation about the National Guard with Senator Kit Bond, my fellow co-chair of the Senate's National Guard Caucus, and Senator Ben Nelson, a longtime caucus member…

Jeff Bingaman
Sen. Jeff BingamanD-NM · Jan 30, 2007

Mr. President, I rise today with 12 other senators to introduce the bipartisan Essential Air Service Preservation Act of 2007. I am pleased again to have my colleague Senator Snowe as the principal…

John D. Rockefeller IV
Sen. John D. Rockefeller IVD-WV · Jan 30, 2007

Mr. President, I rise today with Senators Schumer, Kohl and Leahy to reintroduce an important bill for all Americans. The bill that we are reintroducing today would reduce barriers to affordable…

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John D. Rockefeller IV
Sen. John D. Rockefeller IVD-WV · Jan 30, 2007

Mr. President, I rise today with Senators Schumer, Kohl and Leahy to reintroduce an important bill for all Americans. The bill that we are reintroducing today would reduce barriers to affordable…

John McCain
Sen. John McCainR-AZ · Jan 30, 2007

Mr. President, I am pleased to join my colleague, Senator Schumer, in sponsoring the ``Keeping the Internet Devoid of Sexual- Predators Act of 2007,'' otherwise known as the KIDS Act. This bill would…

Olympia J. Snowe
Sen. Olympia J. SnoweR-ME · Jan 30, 2007

Mr. President, I rise today to join my colleague, Senator Bingaman, to introduce the bipartisan Essential Air Service Preservation Act. I am proud to join with Senator Bingaman, who has been a…

Norm Coleman
Sen. Norm ColemanR-MN · Jan 30, 2007

Mr. President, today I am introducing a bill to transfer ownership of a 1960s A-12 Blackbird spy plane to the Minnesota Air National Guard Historical Foundation. The legislation will allow the A-12…

Daniel K. Inouye
Sen. Daniel K. InouyeD-HI · Jan 30, 2007

Mr. President, I rise today to introduce a bill to reauthorize the Native Hawaiian Health Care Improvement Act. Senator Akaka joins me in sponsoring this measure. The Native Hawaiian Health Care…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Jan 30, 2007

Mr. President, I am pleased today to join Senators Rockefeller, Kohl and Schumer in introducing legislation to end the use of so-called ``authorized generics'' during the 180-day period that Congress…

Bill Text

Latest available legislative text

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Introduced in SenateIssued January 30, 2007

II

110th CONGRESS

1st Session

S. 438

IN THE SENATE OF THE UNITED STATES

January 30, 2007

Mr. Rockefeller (for himself, Mr. Schumer, Mr. Kohl, and Mr. Leahy) 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

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

(o)

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).

.