FDA Policy/General

FDA May Get $300 Million Boost Under Infrastructure Bill

FDA is poised to get an additional $300 million for improving infrastructure under a revised House reconciliation bill that “reflects a top-line consistent with President Biden’s endorsement of a bill about half the size of the original $3.5 trillion proposal,” according to a report by the Alliance for a Stronger FDA. The $300 million for FDA infrastructure was not included in previous versions of the bill.

“Specifically, Section 31023 of the modified Build Back Better Act provides $150,000,000 for ‘improving technological infrastructure, including through developing integrated systems and improving the interoperability of information technology systems,’ and $150,000,000 for ‘modernizing laboratory infrastructure of, or used by, FDA, including modernization of facilities related to, and supporting, laboratory infrastructure, including through planning for, and the construction, repair, improvement, extension, alteration, demolition, and purchase of, fixed equipment or facilities,’” the group says.

The House has not scheduled any further action at the moment and the viability of the entire reconciliation process is uncertain, the Alliance says. “These new provisions respond to FDA’s needs — as articulated in the FY 22 budget request — for a major infusion of money for technological and physical infrastructure,” it adds.

For now, FDA and other government agencies are operating through 12/3 under a continuing resolution measure, which provides funding at FY 21 levels and limits any new initiatives.

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