FDA Policy/General

FDA ‘Doing Little’ on Social Media Drug Claims: Report

A lengthy Bloomberg Law report says a review of FDA records shows the agency is doing little to cut down on misleading drug claims on social media, despite having released draft social media guidelines in 2004. The report says that since issuing the draft guidance, the agency has “done little to regulate influencers who may or may not have direct ties to the manufacturers, yet tout their success with medications such as Novo Nordisk’s diabetes medication Ozempic (semaglutide) and Pfizer’s migraine drug Nurtec ODT (rimegepant).”

While drug companies, paid social media influencers, and telehealth companies that sell the drugs are required to balance promotional information with warnings about side effects in social media ads, similar to the lengthy FDA-mandated warnings in TV and magazine ads, Bloomberg says, in practice, it found that social media ads often contain limited to no warnings.

In a statement to Bloomberg Law, FDA spokesperson Carly Pflaum said the agency “is strongly committed to protecting public health by helping to ensure that prescription drug promotional communications issued by or on behalf of a drug manufacturer, packer, or distributor are truthful, balanced, and accurately communicated.”

The article says that of the 40 publicly available letters issued by the CDER Office of Prescription Drug Promotion (OPDP) since 2017, only seven dealt with sponsored posts on platforms including Facebook, Instagram, and YouTube. It notes that none of the letters mention TikTok, which didn’t exist when the 2004 draft guidance was issued.

The article quotes OPDP director Catherine Gray from a 9/14 Webinar as acknowledging that emerging social media platforms present new challenges in monitoring prescription drug promotion. It notes that FDA declined a Bloomberg request to interview Gray for the article.

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