Drugs

Accelerated Approval Program ‘Largely Successful’: Analysis

An Amgen analysis published in Therapeutic Innovation & Regulatory Science, says the FDA accelerated approval program for drugs “has been largely successful, with half of accelerated approvals converted to traditional approval in a median time of 3.2 years.” The researchers say recent FDA actions show the agency is appropriately managing the program when a drug approved under accelerated approval fails to confirm a clinical benefit. “Any proposed changes to the program should be based on cumulative experience with the program, rather than outliers,” the researchers say.

The authors say that concerns voiced recently about the program “are based on a small number of examples, and do not reflect overall management of the accelerated approval program over its 30-year history, particularly improvements seen in the last decade in the time from accelerated approval to conversion.”

They write that the small percentage of drugs whose clinical benefit is ultimately not confirmed should not be viewed as a failure of the accelerated approval program. Rather, the researchers say, they represent an expected trade-off in expediting drug development that benefits patients with serious or life-threatening diseases.

The researchers say that any proposed changes to the program “must be carefully crafted to avoid creating disincentives that would reduce access to life-saving treatments under the accelerated approval pathway.” They also write that to the extent that increased public confidence in the program is needed, additional transparency about the status of post-marketing studies could address that concern. “FDA should share publicly on its database more information when a postmarket clinical study milestone is revised, including posting revised milestone dates, as well as a more detailed explanation for extending a study deadline,” the article says. “FDA should include why FDA remains confident in the sponsor’s ability to complete the confirmatory study.”

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