Drugs

Drug Firms Sue to Stop Drug Prices in DTC Ads

Merck, Eli Lilly and Amgen have filed suit in DC federal court seeking to stop an HHS rule to include drug prices in direct-to-consumer ads. Joined by the Association of National Advertisers, the complaint contends that the rule violates the companies’ First Amendment rights, and it would mislead patients about their out-of-pocket costs for prescription drugs.

The companies argue that the “list price is not, as patients will likely infer from the context, a suggested sales price for the retail transactions contemplated in advertisements. Rather, the rule requires manufacturers to use the gross price at which a prescription drug is offered to wholesalers, before rebates, discounts, or any other adjustments are applied.” They also argue that the mandated price figure not only ignores such wholesale price adjustments, but also fails to account for the insurance coverage that a significant majority of Americans have for their retail purchases of prescription drugs.

The HHS rule is expected to go in effect next month.

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