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Proposed CREATES Amendment Could Impede Availability of Affordable Generic Drugs

Last month, legislation intended to help remove barriers preventing generic drugmakers from bringing affordable medicines to market cleared an important hurdle when the Senate Judiciary Committee passed the CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act. Although Sen. Orrin Hatch (R-Utah) withdrew his amendment seeking to inhibit generic drug manufacturers from challenging the validity of brand-name manufacturers' patents (through inter partes review), he has indicated it would be a "top priority" in his remaining months in Congress.

Writing on To the Point, Henry Waxman, Bill Corr, and Kristi Martin explain that, if implemented, Hatch’s amendment would enable brand-name drug manufacturers to maintain "low-quality" patents and delay price competition from generic drugs.

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