Proposed CREATES Amendment Could Impede Availability of Affordable Generic Drugs


Last month, legislation intended to help remove barriers for generic drugmakers to bring 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. But during consideration, Sen. Orrin Hatch (R-Utah) offered an amendment that would inhibit generic drug manufacturers from challenging the validity of brand-name manufacturers’ patents through an administrative remedy known as inter partes review.

Although Sen. Hatch withdrew the amendment, he has indicated it would be a “top priority” in his remaining months in Congress. In a new To the Point post, Henry Waxman, Bill Corr, and Kristi Martin explain that, if implemented, the amendment would enable brand-name drug manufacturers to maintain “low-quality” patents and delay price competition from generic drugs. Read the post to learn why.

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