An Expert Panel Exists To Give Advice To FDA Over Drug Approvals. But Agency Officials Don’t Always Listen.
A new analysis looks at the reasons FDA officials disregard advice from the expert panel -- and much of the time there was a disagreement, the FDA took the more cautious route. Interestingly, the authors also found that disagreement was not more common when panel members had conflicts of interest or when there was more media coverage over the drug.
The FDA Disagrees With Its Own Expert Panels How Often?
As the Food and Drug Administration grapples with rising pressure to approve new medicines more quickly, a new analysis finds the agency disagreed with its expert advisory panels about one-fifth of the time. The disagreements were more likely to occur over safety issues than over approving new products or additional uses for existing products. (Silverman, 7/15)
In other pharmaceutical news —
In A Small Study, A Cancer Vaccine Assist Beats Immunotherapy Drugs Alone
The largest study to date of a “cancer vaccine” plus one of the immunotherapy drugs that has revolutionized cancer treatment found that they kept patients’ tumors in check longer, on average, than drugs alone, but that the benefit was still only a few months for two forms of cancer, study sponsor Neon Therapeutics reported on Monday. It was a hint that an experimental therapy often described as the next great hope for immune-based approaches to fighting cancer will not be a silver bullet. (Begley, 7/15)