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Capitol Health Call | December 14, 2011

Pay for Delay of Generics

Mike Mitka

JAMA. 2011;306(22):2443. doi:10.1001/jama.2011.1767.

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Brand name pharmaceutical manufacturers are continuing to pay generic drug makers to keep their products out of the US market, said Sen Chuck Grassley (R, Iowa), ranking member of the Judiciary Committee.

Grassley, a coauthor of the Preserve Access to Affordable Generic Drugs Act (S 27 [http://thomas.loc.gov]), which would prohibit pay-for-delay agreements, made his observation following the October release of a Federal Trade Commission (FTC) report on patent agreements filed in fiscal year 2011. The FTC received 156 final resolutions of patent disputes between manufacturers of brand-name drugs vs generic drug makers; of these, 28 final settlements involved both compensation to the generic manufacturer and a restriction on the generic manufacturer's ability to market its product. These settlements involved 25 different brand name pharmaceutical products with combined annual US sales of more than $9 billion, the FTC reported (http://tinyurl.com/76rsj72).

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Mitka M. Pay for Delay of Generics. JAMA. 2011;306(22):2443. doi:10.1001/jama.2011.1767.

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