S 369 · 111th Congress 2009โ€“2011, ended

Preserve Access to Affordable Generics Act

Latest action · Feb 2, 2010 By Senator Leahy from Committee on the Judiciary filed written report. Report No. 111-123. Minority views filed.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedFeb 3, 2009
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Preserve Access to Affordable Generics Act - Declares as the purposes of this Act to: (1) enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers; and (2) support the purpose and intent of antitrust laws by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers.

Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the drug product for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the procompetitive benefits of the agreement outweigh the anticompetitive effects.

Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by a new drug application holder to a filer of an abbreviated new drug application is the right to market the drug product in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right that would prevent the marketing of such drug, a payment for reasonable litigation expenses not exceeding $7.5 million, and a covenant not to sue on any claim that the filer infringes a U.S. patent.

Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the FTC or a court that an agreement has violated this Act.

Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

Cosponsors 11

Members who signed on, in the order they did. Signatures ran from Feb 3, 2009 to Aug 2, 2010; 4 are original cosponsors, there from the day it was introduced.

SeatCosponsorSigned on
R-IAChuck GrassleyOriginalFeb 3, 2009
D-ILRichard J. DurbinOriginalFeb 3, 2009
D-WIRussell D. FeingoldOriginalFeb 3, 2009
D-OHSherrod BrownOriginalFeb 3, 2009
R-MESusan M. CollinsMay 12, 2009
D-MNAmy KlobucharJun 1, 2009
D-FLBill NelsonJun 23, 2009
D-MNAl FrankenSep 9, 2009
D-NDByron L. DorganFeb 24, 2010
D-SDTim JohnsonJul 26, 2010
I-VTBernard SandersAug 2, 2010

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

ChamberCommitteeWhat it did
SenateJudiciary Committee
Referred Feb 3, 2009Markup Oct 15, 2009Reported Oct 15, 2009

Actions 7

Everything that happened, newest first.

  1. Feb 2, 2010By Senator Leahy from Committee on the Judiciary filed written report. Report No. 111-123. Minority views filed.
  2. Oct 15, 2009Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
  3. Oct 15, 2009Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. Without written report.
  4. Oct 15, 2009Placed on Senate Legislative Calendar under General Orders. Calendar No. 183.
  5. Feb 3, 2009Introduced in Senate

In the Congressional Record 1

Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.

WhereIn the RecordMembersDate
SenateDebate and remarks S1433Text printed S1433Herb Kohl D-WI (text)Feb 3, 2009

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Committee report

Congressional Budget Office cost estimates 4

  1. Jun 16, 2010S. 369, Preserve Access to Affordable Generics Act (Updated table)<p>Updated table for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009.</p>
  2. Jun 16, 2010S. 369, Preserve Access to Affordable Generics Act (Updated table)Updated table for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009.
  3. Jan 28, 2010S. 369, Preserve Access to Affordable Generics Act<p>Cost estimate for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009. Note: Numbers updated in <a href="http://www.cbo.gov/ftpdocs/115xx/doc11582/s369_updated_table.pdf">a new table</a> on June 16, 2010.</p>
  4. Jan 28, 2010S. 369, Preserve Access to Affordable Generics ActCost estimate for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009. Note: Numbers updated in a new table on June 16, 2010.

Titles 3

Every title it has carried, official and short, at each stage.

Official Title as Introduced
A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.
Short Titles as Introduced
Preserve Access to Affordable Generics Act
Short Titles as Reported to Senate
Preserve Access to Affordable Generics Act

Subjects

Assigned by the Library of Congress. Policy area: Commerce.

Text 2

Each version as it was printed, newest first.

  1. Oct 15, 2009Reported to Senate
  2. Feb 3, 2009Introduced in Senate

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.