FDA Policy/General

User Fee Reauthorization Signed Into Law

A continuing resolution (see earlier story), which includes the five-year reauthorization of FDA’s user fee programs, is signed into law by President Biden on 9/30. Earlier in the day, the resolution was passed by a House vote of 230-201. The previous day, the Senate passed it in a 72-25 vote.

In floor remarks before the passing vote, House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) criticized Senate minority leader Mitch McConnell (R-KY) for blocking bipartisan policy riders that were negotiated earlier in the year that would have reformed several programs at the agency (see earlier story). “That bipartisan legislation would strengthen the integrity of the accelerated approval program, foster innovation, improve clinical trial diversity, and reauthorize the agency’s medical product user fee programs,” he said.

“Unfortunately,” Pallone continued, “despite this progress, Senate minority leader McConnell decided to stand in the way of enacting bipartisan policies to improve public health. Senator McConnell threatened to hold up government funding if our FDA reforms were included in the continuing resolution we are debating today. While I am pleased that we are reauthorizing user fees, which will prevent layoffs at the agency and allow FDA to continue its mission, I will continue pushing for the widely supported improvements at the agency. I have secured commitments from Senators Murray and Burr, as well as ranking member Rodgers, to continue working to finalize a package of FDA reforms before this continuing resolution expires in December, and I look forward to taking meaningful action in the near future.”

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