FDA Policy/General

Specialty Doctors Losing Faith in FDA: Survey

A Spherix Global Insights survey of 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology found that confidence in FDA is swiftly diminishing. The survey says only 36% of respondents expressed a high level of assurance in the agency, with nearly one-half saying their confidence in FDA has eroded in the past year.

“Sentiment is most negative as it relates to being unbiased/apolitical, the speed of NDA reviews, and transparency with the medical community,” Spherix says. “The dissatisfaction seems to stem from unpredictable and unexpected moves from the agency, which differ by specialty.”

More than 70% of all surveyed physicians agree that FDA should establish a standard for holding an advisory committee and about 40% say the agency should always follow an advisory committee’s recommendations. In the case of a split advisory committee recommendation, only 42% trust FDA to make the final decision on a product with the patients’ best interests in mind. Many respondents also raised the question of whether the FDA focus on Covid-19 vaccines and treatments is causing other product approvals to be delayed and/or deprioritized.

“From the perspective of specialty physicians,” Spherix says, “it is not a matter of being too lax or too stringent, but rather a lack of consistency and transparency when evaluating new drugs for approval that has led to physician wariness.”

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