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James C. Stansel
Published 6:38 p.m. ET Oct. 16, 2017

We will continue to work with the FDA: Opposing view

Ensuring patient access to medicines that are revolutionizing how we fight disease is critically important. Equally so is understanding when additional safeguards are required to ensure a medicine’s benefits outweigh its risks.

In such cases, the Food and Drug Administration may require the biopharmaceutical company that manufactures the medicine to implement additional procedures, called Risk Evaluation and Mitigation Strategies (REMS), to facilitate safe use of the medicine.

REMS are a critical regulatory tool for protecting patient safety. Their elements can take many different forms and vary by medicine. In some cases, the FDA may impose an additional level of scrutiny that goes by the acronym of ETASU, or elements to assure safe use to mitigate a serious risk included in the labeling.

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Some critics claim biopharmaceutical companies use the process to block companies from obtaining samples of medicines for testing in bioequivalence studies and bringing generic versions to market. However, this fails to acknowledge that companies have provided access when adequate assurances have been made with respect to compliance, and that many medicines subject to REMS with ETASU already have generic competitors. In fact, of the 43 instances, 10 are shared systems, meaning generic versions have been approved.

We believe we can further improve patient access and affordability through reforms that promote competition and modernize the drug discovery and development process.

We applaud the FDA for streamlining and expediting the generic drug approval process. Its recent initiative to publish a list of off-patent, off-exclusivity medicines without approved generics and updating its internal procedures to allow expedited review for some generic medicines is further evidence the FDA is correctly focused on promoting a competitive marketplace that works for patients.

The U.S. biopharmaceutical industry leads the world in innovation and will continue to work with the FDA to promote competition and protect patient safety.

James C. Stansel is general counsel of the Pharmaceutical Research and Manufacturers of America.

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