Drugs

FDA Reform Needed to Address Lack of Urgency: Forbes

FDA’s alleged foot dragging in recommending updated Covid-19 vaccines last month and in approving the release of new Monkeypox vaccines illustrates the need to reform the agency, according to a 7/18 Forbes article by Pacific Research Institute president Sally Pipes in which she takes issue with what she describes as the agency’s insufficient urgency in dealing with the Covid emergency, which it risks repeating with Monkeypox outbreaks.

“It’s been roughly six months since omicron caused COVID cases to spike,” she writes. “Yet the FDA waited until a new, more transmissible version of the virus was threatening a wave of cases and reinfections to recommend updating the vaccines, which are based on a two-year-old version of the virus that bears less and less resemblance to today’s offshoots.”

By the time the revamped vaccines are available beginning in October, the current surge will have long peaked, Pipes complains. “The science is not the problem,” she says, “but the regulatory state is. As soon as scientists identified omicron last fall, Moderna and Pfizer started working on reformulating their shots to target its BA.1 variant. More than 200 days later, the FDA hadn’t met to discuss the new vaccines. By the time the agency’s vaccine advisors finally convened last month, BA.4 and BA.5 were the dominant strains. That forced vaccine-makers to pivot and create new formulas for their shots.”

In the article, Pipes also turns to the recently stalled user fee reauthorization, specifically lawmakers’ actions to revamp the accelerated approval process, which she says could lead to ensnaring it in more red tape. “As midterm elections approach, FDA reform should be on the ballot,” she says. “Lawmakers would do well to advance policies that would cure the agency's sclerosis.”

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

Read more

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