Refusal to Deal Under FDA Imposed Risk Evaluation and Mitigation Strategies (REMS): Economic Considerations

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Robert Maness, Brian Segers, Apr 29, 2014

The Federal Trade Commission, as part of its ongoing enforcement of perceived anticompetitive abuse of the regulatory and legal structure in the pharmaceutical industry, has turned its gaze to branded pharmaceutical firms’ refusal to sell samples of restricted distribution products to firms seeking approval to market generic versions.

The types of restricted distribution arrangements that gave rise to these concerns are relatively new, dating from Food and Drug Administration Amendments Act of 2007. The FDAAA granted the FDA powers to require branded firms to design and implement risk evaluation and mitigation strategies for drugs with potentially serious and significant side effects. REMS requirements include a virtual continuum of potential distribution restrictions including requirements to distribute medication guidelines to patients, monitoring and reporting of adverse events, communication plans to disseminate safety information to healthcare providers, certification and training of healthcare providers and pharmacies, and limited distribution to only registered cites of service. The most severe restrictions include Elements to Assure Safe Use and Implementation Systems.

REMS restrictions in one form or another became increasingly common in new drug approvals. However, more recently, the FDA has been reducing the number of products with REMS designations. …

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