FDA Policy/General

House Subcommittee OKs $257 Million FDA Boost

The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 6/25 has approved by voice vote FDA’s s fiscal year 2022 budget bill. Under the measure, the agency would receive $3.471 billion in discretionary funding in the bill, an increase of $257 million (8%) above the FY 2021 enacted level.

“Total funding for FDA, including revenue from user fees, is $6.288 billion,” a committee notice says. “Within this total, the committee provides a targeted increase of $72 million to address the opioid crisis, medical supply chain surveillance, rare cancers, and increasing and strengthening inspections. It also includes a $65 million increase to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and addresses heavy metals in baby food. The bill also appropriates $50 million to accelerate medical product development as authorized in the 21st Century Cures Act.”

The Alliance for a Stronger FDA had this to say: “We are grateful for the House’s support of FDA and appreciate that its proposed increase in BA funding will go a long way toward addressing the agency’s many resource needs. In any year, a $257 million/8% increase for FDA is substantial and meaningful. For that, we thank the members of the House subcommittee. We will work with the Senate to achieve a similarly large commitment to FDA’s FY 22 funding needs. The drive to strengthen the FDA is a multi-year marathon, not a sprint, and the Alliance will continue to advocate for critical funding to strengthen the agency.”

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