FDA Rethinking Weight Loss Standards: A Test Case for Patient-Focused Drug Development
This article was originally published in RPM Report
The Center for Drug Evaluation & Research is working with George Washington University as a “neutral convener” to rethink weight loss drug development standards. That may make for an unexpected legacy from the wave of failed weight loss candidates from 2010: a whole new approach to drug development guidance from FDA.
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A common theme in FDA’s review of three different weight loss drugs has been discussion of whether a Risk Evaluation & Mitigation Strategy program can help assure appropriate use of the therapies. FDA clearly thinks the answer is “no.” But that doesn’t end the discussion of what tools can be used to help curb off-label use.
The following is an excerpt from FDA Commissioner Margaret Hamburg’s keynote address to the Food & Drug Law Institute annual meeting in Washington April 4.
FDA’s idea to encourage “voluntary” submission of pharmacogenomic data started slow—but the program has paid significant dividends for the agency. In addition to building knowledge and advancing the use of PKG in drug regulation, it has also won over industry and become a case study to support broader funding of regulatory science.