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Generic Drug Development: Stakeholders' Views of Risk Evaluation and Mitigation Strategies Differ

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Report Type Reports and Testimonies
Report Date Oct. 15, 2019
Release Date Nov. 14, 2019
Report No. GAO-20-94
Summary:

The Food and Drug Administration can require drug companies to establish risk-reduction strategies for drugs with serious safety concerns to help ensure their benefits outweigh their risks. For example, a company’s strategy may include restricting a drug’s distribution to prescribers with special training.

Some strategies like these have been used to keep drugs out of the hands of companies looking to develop generic versions of them, according to FDA and the Federal Trade Commission.

In response, FDA and FTC have tried to make drug samples easier to obtain. Generic drug company representatives said some of these efforts have had mixed results.

Pills spilling out from prescription bottle

Pills spilling out from prescription bottle

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