Biologics

Lawyers Analyze ‘Hot-Button’ Special Counsel Letter

Two Mintz attorneys say it will be important to watch and see what new leadership at HHS and Democrats and Republicans in Congress will do with a 3/31 letter from special counsel Henry Kerner to President Joe Biden faulting the way FDA handled a Team Biologics whistleblower complaint that alleged improprieties in compliance inspections at vaccine manufacturing facilities. In their online post, Jane Haviland and Joanne Hawana say the issue could lead to additional investigation and potentially public hearings, especially with congressional reauthorization of various user fee programs ahead as must-pass items for 2022.

The post reviews the whistleblower’s complaints and the concerns expressed by Kerner about FDA’s investigation.

“It is almost certain that these findings and special counsel Kerner’s 3/31 letter will become a hot-button issue for FDA to respond to and defend as Congress begins its work to reauthorize prescription drug, biologic, and medical device user fee programs, which are expected to include significant increases in funding for the agency’s biologics Center in particular (which oversees vaccines, cell therapies, gene therapies, blood products, and others,” the attorneys conclude. “A controversy that involves the relatively small Team Biologics also has the potential to adversely affect the public’s perception of the safety of Covid-19 vaccines that are actively being rolled out to communities and may cause an increase in vaccine skepticism.”

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