Drugs

FDA Making Less Use of Advisory Committees: Analysis

FDA has been making less use of human drug advisory committees, scheduling only 23 meetings this year, according to an analysis by Eye on FDA. There are 31 total advisory committees, with 18 of them relating to human drugs. The report says that 19 of the 23 meetings were related to approval of a new medicine.

“Granted,” it says, “the year is not over, but given the organizational needs of holding such a meeting, FDA usually schedules them a few months in advance. There are unlikely to be any new ones scheduled for 2019, particularly given the holiday season will soon be upon us.”

The report theorizes that one possible reason for less consultation with experts is the emergence and uptake of breakthrough therapy status. “This designation involves a more frequent and high level of consultation between the agency and the sponsor of a new drug application,” it says. “The enhanced interaction between the drug sponsor and the agency may address many of the issues for which the agency would have otherwise sought consultation with experts.”

Another possible explanation, the report says, is that there are fewer drugs to review. The number of new molecular entities approved this year is lower than in 2018.

“Whatever the cause,” the article concludes, “the notion that there are fewer advisory committees may lead some to feel there is less transparency to the process of approval. While they are long, and sometimes quite arduous to sit through, they are a setting in which one gets to see deliberation in action with respect to the approval process…. Moreover, there is an opportunity for public input.”

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