FDA Policy/General

Attorneys Caution Hill, FDA on Speech Restraint

Attorneys Bert Rein and Megan Brown (Wiley Rein) say that government legislators and regulators should “think long and hard before using any speech restraint or compelled disclosure to pursue their consumption preferences or policy goals.” Writing in a Washington Legal Foundation Legal Opinion Letter, the two say that while the commercial speech doctrine remains in flux and somewhat unsettled, the direction of its development points to increasing constitutional sensitivity about the value of commercial speech to sellers and consumers in a free-market economy.

“A healthy respect for First Amendment principles, careful analysis of legitimate justifications for commercial speech restrictions, and an exacting review of the fit between any proposed limitation and those goals are well advised before implementing any commercial speech restraint,” the attorneys write.

They say a precautionary checklist for First Amendment compliance should address:

avoiding acting to suppress consumer choice;
not overusing a “deceptive or misleading” rationale; and
realizing that mandatory disclosure unrelated to curing deception does not get a First Amendment pass.

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