Drugs

Loper Bright May End FDA Speech Ban: Attorney

Attorney James Beck (Reed Smith) says the Supreme Court decision in Loper Bright overturning judicial deference to administrative agencies could lead to significant changes to FDA’s ban on off-label speech. Writing online in the Drug and Device Law Blog, Beck says FDA has been relying on a “very suspect assemblage of statutory and regulatory provisions that don’t really fit together to create such a sweeping ban,” especially since nothing in the Federal Food, Drug, and Cosmetic Act (FFDCA) specifically bans the promotion or marketing of drugs for off-label use.

Since Loper Bright essentially tells courts to ignore administrative interpretations of unclear laws and instead give statutes “the reading the court would have reached if no agency were involved,” Beck says it is unlikely that the best reading of the FFDCA is a nearly complete ban on off-label speech without regard to truth or scientific merit.

He also points to another recent Supreme Court decision that the Administrative Procedure Act statute of limitations runs from whenever a plaintiff is actually injured as leading to a Loper Bright challenge to the basis for a ban on off-label speech whenever a plaintiff is injured by a new application of the ban. There are pending off-label speech guidances on “misinformation” and “communication with healthcare providers” that could lead to such a challenge, he writes.

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