Drugs

Did Recarbrio Approval Break FDA Rules?

A BMJ investigation asks whether FDA broke its own rules requiring substantial evidence that a drug is effective when it approved in 7/2019 Merck’s antibiotic Recarbrio (relebactam and imipenem-cilastin). “Despite the absence of any clinical studies to provide substantial evidence of its effectiveness, the agency approved the drug, a product 40 times more expensive than an existing generic alternative,” the article says.

The article says FDA medical reviewers had raised concerns about Recabrio’s efficacy. They said the efficacy results that were submitted showed that Recabrio could be as much as 21.3% worse than a control group that received only imipenem.

Despite three clinical studies not providing substantial evidence of effectiveness, FDA approved Recarbrio, without presenting it to an advisory committee, BMJ says. “Instead of basing its decision on the clinical trials in Merck’s application,” it says, “FDA’s determination of Recarbrio’s efficacy was based partly on past evidence that imipenem was effective and partly, to justify the new relebactam component, on in vitro studies and animal models of infection, rather than evidence from human trials as required by law.”

And while agency regulations say that only the CDER director (principal deputy commissioner Janet Woodcock at the time) can waive in whole or in part the “adequate and well-controlled studies” approval criteria, there is no such waiver approval in the file, the journal was told by FDA. Woodcock told the journal she was not aware that the Recarbrio studies did not provide substantial evidence of effectiveness since such decisions are ordinarily delegated several levels down in the organization.

Merck did not respond to an FDA Webview request for comment.

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