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Will REMS Delay Generics? Revlimid Petition May Help Determine The Answer

This article was originally published in The Pink Sheet Daily

Executive Summary

Dr. Reddy’s asks FDA to spell out policy to assure that new Risk Evaluation and Mitigation Strategies will be used to block generics. Celgene’s refusal to make Revlimid available for bioequivalence study is at issue.

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REMS “Abuses” Concern FDA, But Can Scolding Help Speed Generic Entry?

Brand name companies’ use of restricted distribution programs to block the development of generic drugs has been an unintended consequence of the FDA Amendments Act of 2007. The generics industry has long complained that the use of FDA-required risk management plans prevents access to affordable medicines. While that battle has ranged in the courts, FDA has remained quiet on the subject. Until now.

Generic Companies Gain Little From FDA Decision On Access To REMS Drugs

The agency says the FDAAA does not allow a REMS to state that a brand sponsor cannot use a limited distribution program to prevent generic drug maker’s access to a product for bioequivalence testing.

REMS Hurdles To Generic Entry: From Brand Access To Patent Claims

Can generic manufacturers use patented elements of a drug distribution plan? Will FDA accept an alternative REMS program? Will brand companies have to provide access to their products? As the number of brand products subject to REMS grows, so do the unanswered questions for generic firms.

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