FDA Policy/General

‘Clean’ User Fee Bill Added to Continuing Resolution

In an expected move to avert sending pink slips to thousands of FDA employees next month, House and Senate negotiators have come to terms to reauthorize the agency’s user fee programs under a clean — absent any policy/program riders that the two chambers have earlier sought — measure that will be attached to a continuing resolution bill this week.

Energy and Commerce Committee Chairman Frank Pallone (D-NJ) had this to say after announcing the agreement: “In June, the House passed a user fee reauthorization package on time with overwhelming bipartisan support. After the House passed its user fee package, bipartisan Energy and Commerce and HELP leaders came to agreement on language to cover many significant policy areas that we wanted included in the continuing resolution. Unfortunately, Senate Republican leadership blocked these policy agreements from being included. All four corners committed to returning to the negotiating table ahead of the December government funding deadline to revisit these key priorities. I’m going to continue pushing to advance as much of the House-passed legislation as possible.”

Senators Patty Murray (D-WA) and Richard Burr (R-NC), chair and ranking member of the Health, Education, Labor, and Pensions (HELP) Committee said after the agreement was reached that there is “more work ahead this Congress to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts. As part of our agreement, we and our House counterparts are committed to continuing that work, and including strong, bipartisan legislation in a robust end of year package.”

A section-by-section summary of the language included in the continuing resolution is available here (p.19 begins user fee reauthorization).

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