Drugs

FDA Monitoring Social Media Drug Promotion: Post

Attorneys Dominic DiSabatino and Cortney Inman (SheppardMullin) say an 8/11 Warning Letter issued by the CDER Office of Prescription Drug Promotion (OPDP) to Exeltis USA over its Facebook post for Slynd (drospirenone) oral progestin tablets, demonstrates that OPDP is “closely monitoring social media drug promotion and will respond to clear violations of labeling and advertising regulations.” The attorneys’ online post says this was only the second OPDP Warning Letter issued this year, both of which cited false and misleading promotional messaging.

“This letter follows a trend of OPDP concentrating on low-hanging fruit,” the attorneys write, “singling out the most noticeable violations that present the greatest concerns for public health. Indeed, this letter is fairly straightforward and underscores some foundational principles of drug advertising and promotion: provide a balanced presentation of safety and risks, and ensure that efficacy claims are consistent with clinical trial data.”

The Warning Letter said Exeltis failed to include any Slynd risk information in its social media post and also failed to submit the promotional material to FDA before it was posted online.

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