FDA Policy/General

Trump Picks Health Policy Adviser Overton as FDA Commissioner Nominee

President Donald Trump has selected White House health policy adviser Heidi Overton as his nominee to become FDA commissioner, according to multiple media reports. If confirmed by the Senate, Overton would succeed former commissioner Marty Makary, who resigned in May.

Overton currently serves as deputy director of the White House Domestic Policy Council. She previously worked at the conservative America First Policy Institute, where she served as chief policy officer and vice chair of its Center for a Healthy America. She also served as a White House Fellow during the first Trump administration. Overton earned her medical degree from the University of New Mexico and a PhD in clinical investigation from the Johns Hopkins Bloomberg School of Public Health.

Overton would inherit an agency working to rebuild relationships with the pharmaceutical industry and restore staffing following months of leadership turnover and organizational disruption. FDA has lost more than 3,000 employees during the Trump administration’s restructuring efforts, and several senior positions have remained under interim leadership, including the directors of both CDER and CBER

Overton’s close ties to Makary could concern industry and FDA career staff. She had worked with Makary and defended him during the administration's internal disputes, according to media reports.

Overton's connection to the administration's vaccine policy also is likely to receive significant scrutiny during the confirmation process. She appeared at a White House event last week (see story) associated with an executive order proposing changes to the nation's childhood vaccination recommendations.

Her views and role in developing the administration's health policies are expected to become a major focus if the nomination moves forward. Axios reported that some critics have questioned whether Overton has sufficient management experience for an agency as large and complex as FDA, while supporters have praised her health-policy background and familiarity with the administration's agenda.

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