Drugs

Gottlieb Wins End to Hiring Freeze at FDA

FDA commissioner Scott Gottlieb told a House FDA Appropriations Subcommittee hearing 5/25 that the Trump Administration’s January-ordered hiring freeze at FDA has been lifted and the agency is expediting the addition of new hires. “In getting the hiring freeze lifted so quickly, Dr. Gottlieb and his team have demonstrated their ability to swiftly accomplish significant internal victories,” observed the Alliance for a Stronger FDA. “It gets him out of the blocks well and is an important sign of his ability to move things through the HHS bureaucracy and his attention to administrative matters. As we all know, such matters can be mundane, but are extremely important to the well-functioning of the agency. While we still need to understand how the hiring will work, the Alliance views FDA workforce issues as one of the most important issues the new commissioner will face.”

In its weekly analysis, the Alliance outlines its opposition to the Administration’s budget request seeking more than $1 billion in new user fees to offset reductions in the agency’s budget authority (BA), noting that Congress is “unlikely to adopt” the proposal. “Apart from these practical reasons why expanded user fee[s] won’t happen, there is also our concern that user fee funds should not be a substitute for budget authority funds,” the Alliance says. “They serve different purposes. BA appropriations pay for fulfilling FDA’s mission and responsibilities. This includes safe and effective medical products and safe foods, and also a myriad of other Congressionally-mandated public health and consumer protection programs.

“In contrast,” the Alliance continues, “user fees supplement the agency’s BA appropriation and pay for improvements; they were never intended to replace the agency’s BA appropriation. They result from carefully balanced negotiations in which FDA commits to undertake certain programs and meet certain metrics in exchange for the user fees that medical product industries have agreed to pay.”

The Alliance says it plans to work with Congress “to find ways to support the agency in the new fiscal year.”

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