FDA Policy/General

Califf Says GOP Budget Cuts Would Devastate FDA

FDA commissioner Robert Califf says that proposed budget cuts of up to 22% being floated by Republican lawmakers would have a devasting effect on the agency and the industries it serves. Testifying at a 3/29 House Appropriations Subcommittee hearing, Califf was asked by ranking member Sanford Bishop (D-GA) to elaborate on the impact to FDA programs if the proposed cuts occurred.

Califf replied that not only would appropriated funds see cuts, but user fees would also feel the burn. He said there’s a trigger in the user fee programs that says if the budget authority drops to a certain level, then user fees also drop. So, when both budgeted amounts are decreased “the result is going to be that our innovative companies are going to suffer,” he told the hearing. “They won't get their products reviewed on time. That’ll cost jobs and that will cause our industries to move overseas.” When it comes to inspections, he said these would drop between 20 and 35%, which means that things like interdicting opioids at the border, and dealing with contaminated products would all “fall down.”

During the hearing’s conclusion, Califf was asked by subcommittee chair Andy Harris (R-MD) whether concerns about inspection schedules and suspect drug products coming into the U.S., could be eased with a drug batch testing program at the border to help identify bad players who in turn could be banned from importing product into the U.S. Califf responded that theoretically it could and he would like CDER officials to be able to respond further to the question.

Under such a plan, Califf said he would not be worried about the innovator side, but the generic industry is more worrisome. He said that because 90% of prescriptions written in the U.S. are for generics, such a maneuver would increase the cost of these. “The competition of the generic industry is almost entirely on the basis of cost right now and it concerns us a lot at the FDA,” he said. “We need a hard look at that industry to make sure that quality is built in, which is going to cost a little bit more.”

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