FDA Policy/General

Consumers Concerned About DTC Ads

The Patient, Consumer, and Public Health Coalition took advantage of an FDA request for comment on a proposed direct-to-consumer (DTC) ad survey to raise again concerns about the DTC ads themselves. The 13 organizations in the coalition say they are “very concerned about the impact of DTC ads on prescriptions, and are especially disappointed at FDA’s failure to follow through on the agency’s previous proposals to put risk information on a more equal footing with information about benefits. Due to FDA’s continued acquiescence to companies’ proposed ads, DTC ads use the power of an expensive advertising campaign to persuade patients to use medical products that may not be safe or appropriate for them. Rather than empowering consumers, direct-to-consumer ads expose consumers to the most expensive persuasion money can buy.”

Commenting on the survey proposal itself, Lilly says the agency should create separate surveys to more thoroughly and clearly measure certain aspects of the proposed survey. It notes that the projected 35% response rate seems optimistically high given the survey length and effort required of respondents. And it recommends using an online survey rather than a mailed paper form.

Merck makes suggestions for wording changes in the survey document to make it easier for consumers to understand. And AbbVie calls on FDA to account in the survey for the variety of media types through which consumers are exposed to DTC ads.

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