FDA Policy/General

FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

One of the FDA items in the HHS recently published Unified Agenda would, if finalized, fundamentally reshape the landscape of prescription drug marketing in the U.S. Sheppard attorneys Dominic DiSabatino and Audrey Mercer write in their firm’s FDA Law Update that under the proposed rule, drug manufacturers would no longer be able to satisfy their statutory disclosure obligations by directing radio and TV audiences to a Web site, toll-free telephone number, or printed insert.

“Instead,” the attorneys say, “direct-to-consumer (DTC) ads broadcast through media like radio and television would be required to disclose all relevant risk and safety information to consumers within the confines of the ad itself.”

FDA is justifying the proposal, the attorneys say, by claiming it would close what the agency considers to be an “adequate provision loophole” that it says has allowed drug companies to withhold vital safety information in DTC ads.

DiSabatino and Mercer suggest that almost all commercials would be unable to accommodate the volume of safety disclosures that the FDA-approved labeling requires. Thus, they say, companies would be forced to buy significantly more airtime, compress their core marketing message, shift entirely to help-seeking ads that don’t have a fair balance requirement, or exit broadcast marketing completely.

The analysis says the proposal is likely to receive significant pushback not only from drug companies but also from media companies that depend on drug ads for revenue. “A meaningful reduction in pharmaceutical ad spend could have ripple effects across the entire media and broadcast ecosystem,” it says.

DiSabatino and Mercer conclude that if the proposed rule comes to fruition, it “will almost certainly usher in a period of significant regulatory uncertainty in the pharmaceutical DTC advertising space.”

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