FDA Policy/General

Gottlieb Brings On 3 Hill Staffers for Advisor Roles

FDA commissioner Scott Gottlieb has brought on three former Capitol Hill staffers as part of his team of advisors. John Martin has been appointed principal associate commissioner for legislation. He previously served as legislative director for Senator Tom Cotton (R-AR). Martin will advise the commissioner on legislative activities and support the agency’s involvement with Congress on priority issues, including the user fee programs.

Lowell Schiller has been appointed as a senior counselor to the commissioner. Previously, he served as senior counsel to Health, Education, Labor, and Pensions Committee chairman Lamar Alexander (R-TN). As part of his committee work, Schiller conducted congressional investigations and other oversight, and helped draft legislation including the 21st Century Cures Act. Earlier in his career, Lowell was at Sidley Austin LLP as a litigator specializing in appeals, dispositive motions, and federal agency disputes, with a focus on matters involving federal health laws including the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. At FDA, Lowell will be providing policy advice to the commissioner on crosscutting issues, inter-departmental engagement, and areas of programmatic importance to the agency. He will also be providing policy support for science-based decision-making.

And Carly McWilliams has been appointed senior advisor to the commissioner. She previously worked for leadership on the House Energy and Commerce Committee, and her duties included all issues pertaining to FDA and emergency preparedness. McWilliams was actively involved in the FDA Safety and Innovation Act, the Pandemic and All-Hazards Preparedness Reauthorization Act, Drug Quality and Security Act, the Microbead-Free Waters Act, and most recently the 21st Century Cures Act.

At FDA, McWilliams will be working on several high-profile policy initiatives and priority issues for the commissioner. She will focus on generating broad-based support and building coalitions to promote activities central to FDA’s public health mission. She will also be helping Gottlieb prepare public remarks and testimony.

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