Drugs

FDA Accelerated Approvals Down This Year: AP

FDA has granted fewer NDA/BLA accelerated approvals this year than the previous five years after FDA began taking steps to tighten the accelerated approval process for drugs, telling sponsors they need to have confirmation studies underway before products are approved under the expedited pathway. An Associated Press report quotes agency commissioner Robert Califf as saying FDA needs “more teeth in terms of getting the confirmatory trials started before accelerated approval. Once approval occurs, it is very difficult to hold back the marketers.”

The story reports that accelerated approvals slowed this year as Congress, government watchdogs, and even some agency officials started to take shots at the controversial pathway.

While academics have long complained that accelerated approval has led to a glut of expensive, unproven drugs, particularly for cancer, AP says, the 2021 approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease set off a firestorm of criticism, including investigations of agency decision-making by the HHS inspector general and Congress.

“Amid the latest controversy,” the story says, “FDA leaders have taken unprecedented steps suggesting a tougher stance on accelerated approval: nudging drugmakers to remove a growing list of unproven uses for drugs and asking Congress for new powers to expedite removals when companies balk…. In less than two years, FDA has successfully called on drugmakers to remove more than 20 approvals from accelerated drugs, mainly cancer therapies, that failed to show a benefit. That’s more than half the withdrawals in the program’s history.”

AP reports that several drugmakers recently declined agency requests to voluntarily pull their drugs, raising the possibility of long, onerous public hearings to force removal.

“The ability to require drugmakers to have their [confirmatory] studies underway before approval is one part of legislation that congressional lawmakers hope to attach to a massive, end-of-the-year spending bill,” AP reports. “If passed, it would be the biggest overhaul in accelerated approval’s 30-year history.”

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