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H.R. 1344 · 116th Congress

Competitive DRUGS Act of 2019

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019

What it does: CRS summary · Introduced in House · Feb 25, 2019

Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019

This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug.Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug.

However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects.

The bill establishes penalties for violations of the bill.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Competitive DRUGS Act of 2019

Also known as: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019

Latest action (Mar 25, 2019): Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Policy area: Health · Origin: House · Introduced: Feb 25, 2019

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.