Drugs

Ease Off-label Speech Restrictions: WLF

Washington Legal Foundation (WLF) says that FDA should ease its restrictions on manufacturer dissemination of truthful and non-misleading information about off-label uses of approved medical products. In 12/30/16 comments provided in response to an agency 9/1/16 formal request for input, WLF said that the current restrictions prevent doctors from learning about the latest medical advances and violate First Amendment constraints on the government’s power to suppress truthful commercial speech.

The medical community’s knowledge about the safety and efficacy of FDA-approved drugs and medical devices inevitably outpaces the products’ approved labeling, WLF said. While FDA recognizes the importance of off-label uses and does not regulate physician use of FDA-approved products for unapproved uses, it still tries to prevent manufacturers from speaking truthfully about such uses, it said.

The document noted that FDA has been on an “extended losing streak” in the courts in its efforts to defend its restrictive position. According to WLF chief counsel Richard Samp: “For two decades, federal courts have reminded FDA that the First Amendment constrains its power to censor truthful speech by drug and device manufacturers. FDA is to be applauded for agreeing to reexamine its draconian restrictions on manufacturer speech. But public health will continue to suffer unless FDA begins to respect those First Amendment constraints. FDA ought to focus on restricting false or misleading speech, and scientific information can’t be deemed ‘false’ simply because FDA has not yet verified its accuracy.”

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