FDA Policy/General

Odds Low for DTC Ad Ban: Conference Speakers

Speakers at the recent DTC National conference on direct-to-consumer advertising suggested that despite calls for a ban on consumer advertising by HHS secretary Robert F. Kennedy, Jr., the odds of such a ban being implemented remain low. Representing the Healthcare Advertising Coalition, Jim Potter discussed the legal and political landscape for a ban and said that, based on current lobbying efforts and behind-the-scenes discussion with decision makers, he estimated the probability of an outright ban at 25%.

DTC Perspectives CEO Bob Ehrlich says Potter later cited an interview in which FDA commissioner Martin Makary said there is no current plan to pursue a ban.

Also at the conference, consultant Lucy Rose discussed recent actions involving the CDER Office of Prescription Drug Promotion, noting that the office’s consumer research unit has been hit by layoffs and resignations. While reviewers are still in place and enforcing current regulations, Rose said, companies should adopt a cautious and compliant approach during this period of internal disruption.

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

Read more

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