FDA Answers about Safety of Generics

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

In response to news reports that questioned the safety and effectiveness of generic drugs compared with brand drugs FDA Commissioner Scott Gottlieb, MD, and Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued a statement on Feb. 22, 2019 detailing the steps the agency goes through to ensure that generic drugs are safe and effective.

The statement issues a number of facts. According to Gottlieb and Woodcock, generic drugs use the same APIs as brand drugs, function the same way as brand drugs, and have the same risks and benefits. Generic versions of drugs go through an assessment to ensure they meet agency requirements. In addition, generic-drug manufacturing plants are inspected by FDA to ensure compliance with good manufacturing practices. Both brand and generic drugs are monitored for safety and efficacy after they have entered the supply chain.

Consumers must have confidence in the safety and quality of generic medicines. Generic drugs provide affordable access to critical treatments. They are just as safe and effective as their brand counterparts and we stand behind the regulatory efforts that go into ensuring the safety and quality of all generic drugs. Our rigorous standards and inspections apply equally to generic and brand drugs—whether the medicines are being manufactured in Shandong, India, or Indiana, - Gottlieb and Woodcock stated in a press release.

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