FDA Policy/General

DoJ Lawyer Tapped as FDA Chief Counsel

Justice Department attorney Hilary Perkins has been selected to serve as FDA chief counsel. For the past six-plus years, Perkins worked in Justice’s Consumer Protection Branch, most recently as assistant director. Prior to joining the government, she was an associate at Jones Day for six years. Perkins has a law degree from the University of Georgia School of Law.

The previous chief counsel, Robert Foster, who was appointed last month, has now moved to HHS as part of a 3/11 reorganization that created a senior position he is filling — chief counsel for food, research and drugs with authority over the FDA chief counsel, including the Food and Drug Division of HHS’ Office of General Counsel (OGC), and NIH’s branch of OGC.

Interestingly, Perkins most recently defended FDA and the Biden Administration’s policy on the availability of abortion pills in a high-profile case, and she reportedly was chosen as top FDA lawyer by commissioner-designate Marty Makary. The decision to appoint her has been deeply controversial within the administration, according to an Axios report, which added that HHS officials didn’t like the choice but were overridden by the White House.

The Senate HELP committee is due to vote on advancing Makary’ s nomination on Thursday.

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