Drugs

Questions Raised Again About Accelerated Approvals

A Los Angeles Times analysis is joining the chorus of those raising questions about FDA’s use of accelerated approval pathways for drugs whose benefit has not been shown in clinical trials. The newspaper’s report, reprinted by Yahoo! Finance, says that 14 of the 50 (28%) new drugs approved by the agency last year received accelerated approval. “The numbers have jumped from 2018 when just four, or 7%, of the 50 new drugs were approved under those rules,” the newspaper says.

While the accelerated approval pathways were meant to be used in rare cases in which seriously ill patients had no other treatments, the paper says, pressure from the drug industry, patients, and politicians to speed medicines to market now means that most drugs are approved through pathways requiring less evidence and regulatory scrutiny.

The Times refers to its recent investigation into how Covis Pharma has refused FDA’s request to withdraw its Makena (hydroxyprogesterone caproate injection) after an eight-year confirmatory study “unequivocally failed to demonstrate” that Makena worked.

“Dozens of drugs now on the market haven’t yet been backed by studies confirming their effectiveness,” the report says. And there is no requirement that patients be told they have been prescribed one of those drugs, a gap that leads some doctors to feel patients are being misled.

The article quotes Yale University professor of medicine and public health Joseph Ross that “I think people generally assume that when FDA has approved something, there’s overwhelming evidence it is safe and effective.”

FDA told the newspaper it is “committed to ensuring the integrity of the accelerated approval program.”

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