FDA Policy/General

5 Challenges for FDA Commissioner-nominee Scott Gottlieb

Faculty members at the Harvard Kennedy School and Washington University School of Law says FDA commissioner-nominee Scott Gottlieb will face five major challenges at the agency once he is confirmed. Writing in a New England Journal of Medicine Perspective, the two list the challenges as:

deciding what evidence should be required before a drug can be deemed safe and effective;
working with industry throughout the research and development process;
coping with pressure on drug pricing;
making difficult policy choices under the 21^st Century Cures Act; and
addressing concerns about a lack of agency transparency.

“These are just a few issues facing the next FDA commissioner,” the two write, “and they do not address the agency’s broad regulatory authority over food products or new challenges including confronting the application of old statutes to new problems, such as the regulation of mobile health apps, surgical devices using software, or pills with sensors giving physicians feedback on patient adherence. All these challenges require a strongly resourced FDA working at the cutting edge of regulatory science. A commissioner who is able to advocate for such a vision, which includes less dependence on industry funding, will bring the agency into the 21^st century.”

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