Ep. 184 - Califf's FDA reforms & Polaris' Schulman
FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.
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FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.
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