The FDA’s approval of new drugs has notably slowed this year. Annual novel drug approvals averaged 52 in the first Trump Presidency and 48 under Joe Biden, but there have been only 22 in the first seven months of this year. On current trend that would make 38 for the year.
One concern is that regulators are nixing drugs under the false flag of raising scientific standards. A case in point is Replimune’s melanoma treatment, which the FDA rejected …. About a third of patients who hadn’t responded to prior immunotherapy showed a strong response to Replimune’s in a clinical trial.
Tumors shrank in nearly all patients, and responses proved durable over three years. Serious side effects were rare. Oncologists who treated patients in the trial hailed the results. Yet the FDA said the trial was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.”
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Its quibble is that the trial lacked a control group. Vinay Prasad, the head of the biologics division, has long criticized such single-arm studies that have no placebo groups. … Never mind if patients die in the interim.
