S. 27: Preserve Access to Affordable Generics Act

112th Congress · introduced 2011-01-25 · Commerce · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 110.

federal

Follow this bill, step by step

Where it came from: introduced 2011-01-25 · official record
Who proposed it: Sen. Kohl, Herb [D-WI] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Placed on Senate Legislative Calendar under General Orders. Calendar No. 110. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Preserve Access to Affordable Generics Act

Plain summary

Preserve Access to Affordable Generics Act - 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. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug 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 pro-competitive 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 the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug 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 require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such 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 forfeit the 180-day exclusivity period for the marketing of a generic drug 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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Preserve Access to Affordable Generics Act

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Kohl, Herb [D-WI] · 9 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Chuck Grassley (R-IA), Richard J. Durbin (D-IL), Susan M. Collins (R-ME), Amy Klobuchar (D-MN), Bernard Sanders (I-VT)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (3)

Authorization: A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
Resolution: A formal statement or decision by a legislative body. Simple resolutions often only express an opinion or set rules for one chamber; they do not become law.
Statute: A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112s27.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/s>

Record fed-us-cong112-s27 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112