Drugs

FDA Tobacco Ad Rule Violates 1st Amendment: WLF

Washington Legal Foundation (WLF) says an FDA proposed rule to require photorealistic color graphics to accompany textual warnings on cigarette packs violates the First Amendment. In comments to the agency, WLF challenges the FDA claim that because a significant information gap exists, the proposed rule is necessary to inform the public of lesser-known health risks of smoking. “FDA argues that only its mandated photorealistic images can achieve this goal,” WLF says.

According to the comment letter, the agency’s First Amendment analysis is deficient and fails to provide adequate justification for its substantial infringement of manufacturers’ free speech rights.

As part of its argument, WLF cites Thompson v. Western States Medical Center, involving a federal attempt to prohibit pharmacies from advertising compounded drugs. While FDA argued that a ban on advertising was necessary to prevent large-scale drug manufacturing from occurring under the guise of pharmacy compounding, the court held that the government could not restrict pharmacists’ speech as an alternative to regulating their conduct. WLF says that regulating speech must be a last, rather than a first, resort but, that it appears to be the first strategy that FDA considered.

“As long as tobacco use is legal,” the letter concludes, “companies have a right to advertise, market, and label their products free from overburdensome disclosure requirements. FDA’s proposed rule unconstitutionally burdens the right of cigarette manufacturers to market their legal product to consumers.”

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