FDA Policy/General

Sen. Durbin Queries FDA on Drug Promo Staff Cuts

Senator Dick Durbin (D-IL) has written FDA commissioner Marty Makary over concerns about how CDER’s Office of Prescription Drug Promotion (OPDP) can adequately regulate prescription drug advertising after the group was gutted by HHS reduction-in-force efforts and the recent departures of senior leaders (see story). “These departures raise major questions about whether FDA has the personnel, expertise, and capacity to fulfill its mission to regulate prescription drug advertisements — especially in light of your and Secretary Kennedy’s scrutiny of these pharmaceutical promotions,” Durbin wrote in the 5/27 letter.

“Additionally, I am concerned that any gap in regulatory oversight would provide an opening for unscrupulous behavior by industry stakeholders eager to promote medications absent FDA scrutiny,” Durbin continued. “Last month, Novo Nordisk announced a blockbuster partnership to sell Wegovy to patients through telehealth company Hims & Hers. However, there appear to be promotions on the telehealth company’s Website that may be considered advertisements for off-label uses of the drug and also may fail to adhere to FDA’s requirements for providing a ‘fair balance’ of risk information, given the limited safety disclosure that is buried in the text and only accessed via an external link.”

The letter requests answers to the following questions by 6/17:

Who is currently in charge of OPDP?
What is the current number of FDA OPDP employees, broken down by division and function?
Since 1/20, how many total FDA OPDP employees have lost their jobs due to reductions in force; the termination of probationary employees; or other avenues of separation?
How will the reduction in staff compared to 2024 levels affect OPDP’s activities?

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