FDA Policy/General

Rule on Price Info in DTC Ads ‘Illegal’: WLF

Washington Legal Foundation litigation division senior counsel Cory Andrews says the notion of including list prices in drug direct-to-consumer ads could not survive a First Amendment challenge and is outside of FDA’s regulatory authority. Writing in a Forbes online column, Andrews challenges the proposal that was raised earlier this year as part of a HHS blueprint to lower prescription drug prices. He notes that HHS secretary Alex Azar has invoked the idea and FDA commissioner Scott Gottlieb has said that an agency working group will soon study the idea.

“If that study includes a dispassionate legal and constitutional analysis,” Andrews writes, “the working group should recommend that HHS scrub the list-price mandate from its policy blueprint. Not only does FDA lack the statutory authority to impose the mandate, but even if it could legally do so, the regulation cannot survive a First Amendment challenge…. How prescription drugs are priced is an issue of great public importance. But the role government should play in drug pricing is open for debate. Whatever actions FDA regulators end up pursuing, curbing truthful, non-misleading speech about lawful products should always be the last resort.”

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