FDA Policy/General

House Passes $7.1 Billion FDA Spending Bill

The House, Thursday evening, passed FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency, including $3.4 billion in discretionary budget authority and $3.7 billion in authorized user fees. The measure was approved by a vote of 213 to 210.

Meanwhile, Senate appropriators earlier in the week postponed consideration of a fiscal 2027 spending bill that would fund the agency, after a broader dispute over a Republican reconciliation package forced the Senate Appropriations Committee to suspend its markup schedule for the week. The Senate Appropriations Committee had been scheduled to meet 6/4 to mark up the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill, one of the first fiscal 2027 spending measures to move through the Senate this year. The committee's Web site now lists the hearing as "to be rescheduled."

The postponement appears to be collateral damage from a fight over Senate Republicans' budget reconciliation package. Congressional observers reported that Senate leaders shelved committee markups after Democrats signaled plans to force votes related to a proposed "anti-weaponization" reimbursement fund included in reconciliation negotiations. The controversy disrupted the Senate's legislative schedule and led appropriators to delay action on multiple spending bills.

While details of the Senate draft have not been released, appropriators historically have used the Agriculture-FDA bill to address issues ranging from FDA staffing and inspection capacity to food safety oversight and implementation of major regulatory programs.

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