FDA Policy/General

5 FDA Areas of Likely Emphasis in Biden Administration

Three Covington & Burling attorneys say in an online post the incoming administration of President-elect Joe Biden is likely to have these priorities at FDA:

science-based decision-making to highlight career scientific staff and rebuild what is seen as an erosion of public trust in federal health agencies;
continued focus on Covid-19 medical countermeasures to help detect, treat, and prevent the spread of the virus, balancing the space and time needed for FDA career scientists to do their work with the need for the federal government to move expeditiously toward ending the pandemic;
leadership and personnel changes involving individuals that both Democrats and Republicans can support, given a thin margin for either side in the Senate once all races are resolved;
medical product user fee negotiations, which the incoming administration likely will not want to disrupt; and
additional steps to address health disparities that the Covid-19 pandemic has further exposed.

The attorneys also write that the new administration may want to explore the potential for more vigorous judicial enforcement of industry violations, including by seeking consent decrees and making more criminal referrals to the Justice Department. “For imported medical products,” they say, “we expect that the Biden administration will continue the trend of issuing import bans, so-call import alerts, against offending firms. With an increased push to manufacture medical products domestically, there is a potential for even more import bans targeting products from foreign manufacturers.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome