Drugs

Attorneys Look Back, Ahead at FDA

A SheppardMullin report on “2023 Top-of-Mind Issues for Life Sciences Companies” looks at several FDA issues as well as other federal agencies. In 2022, the report says, the CDER Office of Prescription Drug Promotion (OPDP) continued its downward trend in enforcement, issuing just one Warning Letter and three untitled letters. All three of the untitled letters addressed false or misleading benefit and risk presentations. The Warning Letter was related to an unapproved drug product being promoted for Covid-19 treatment.

Looking ahead to 2023, the report says, it is clear that the OPDP is focused on the most repeated and blatant violations that present the biggest and most serious risks to the public health.

The SheppardMullin attorneys write that in 2022 FDA retreated from a flexible approach to regulating digital health in two key areas — the pre-certification program for software as a medical device and the guidance on clinical decision support. “In both cases,” they write, “FDA’s proposed flexible approach was tampered down — in the first case by a lack of authority to implement a more flexible model for premarket clearance of software changes and, in the second, by a desire to provide clarity to industry on how FDA plans to enforce requirements for clinical decision support software.”

The report projects that FDA will “continue to strike a balance between permitting innovations in clinical decision support among other digital products, to flourish and asserting its enforcement authority.”

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