Drugs

CDER Shifting Advertising/Promotion Focus: Analysis

After a flurry of end-of-the year enforcement letters and new guidance documents this month on product communications, it appears a dramatic shift in CDER’s Office of Prescription Drug Promotion (OPDP) enforcement approach is underway, according to an analysis posted on FDAlawblog.com. “After a string of First Amendment case losses by FDA, OPDP appears to be picking its battles carefully when it comes to enforcement letters, focusing on omission and minimization of risk (a cornerstone of FDA’s enforcement activity in this area) as well as pre-approval promotion,” writes attorney Dara Katcher Levy. “Of note, FDA’s First Amendment case losses, to date, dealt with issues pertaining to information disseminated about FDA-approved or FDA-cleared prescription products; these cases did not address communications about investigational products for which there were no approvals/clearances. Consistent with that, we have not seen enforcement letters that solely raise issues around efficacy claims for approved products.”

Levy notes that the agency is particularly paying attention to promotional statements about investigational products. “Of the 11 letters issued in 2016, four dealt with pre-approval promotion,” she adds. “Given that only four of the 70 letters issued by OPDP between 2012 and 2015 dealt with pre-approval promotion, this dramatic increase signals, to us, a sign of things to come in terms of OPDP’s future enforcement activities. With regard to already marketed products, as mentioned above, there were no letters issued in 2016 dealing solely with efficacy claims. The few letters that addressed efficacy did so briefly, with a focus, primarily, on the communication of risk information (see our previous post here). The draft guidances issued this week reflect this approach — indicating flexibility in FDA’s traditional ‘substantial evidence’ standard to substantiate certain product claims.”

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