FDA Policy/General

FDA Again Pushing Uniform National Regulation: Attorney

Attorney Glenn Lammi, chief counsel for Washington Legal Foundation’s (WLF) legal studies division, writes in an online WLF Legal Pulse that FDA is once again appearing in the courts to argue for uniform, national regulation of consumer products. “In the past decade, private litigants and state officials have increasingly undercut regulatory uniformity through state tort and consumer protection lawsuits,” Lammi writes. “Rather than defend its congressional mandate through amicus briefs or other courtroom advocacy, FDA remained mostly silent during that period. This year, under the leadership of commissioner Scott Gottlieb and chief counsel Rebecca Wood, FDA has stepped off the sidelines and is once again promoting uniformity by defending its regulatory role in several third-party legal actions. That is a positive development for the producers and purchasers of FDA-regulated goods, which comprise nearly 25% of U.S. consumer spending.”

Lammi reviews three cases in which FDA has advanced arguments supporting uniformity this year, covering a negligence and product liability suit against Smith & Nephew, opposition to an International Trade Commission investigation over labeling and marketing of certain synthetically produced omega-3 products, and New York City menu labeling.

With consumer products such as prescription drugs, medical devices, packaged food, and cosmetics sold in a national marketplace, Lammi writes, uniform regulation of product approval and labeling lowers manufacturing cost by creating predictable, reliable standards and preventing the need for state-by-state production. Consumers are also assured that they are receiving the same product, with the same warnings and other information, regardless of the state of purchase.

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