Drugs

Califf Warns on User Fee Layoff Notices in September

FDA commissioner Robert Califf warned 7/28 that FDA employees affected by user fee funds could start getting layoff notices in early September if House and Senate leaders don’t complete the user fee reauthorization legislative package in the coming weeks. Lawmakers are at a standstill over language added to the bills that would revamp certain areas of the agency. The user fee programs will sunset on 9/30 without an agreement on the reauthorization package.

As reauthorization efforts stalled earlier this month, Senator Richard Burr (R-NC) introduced a watered-down user fee reauthorization bill that is intended to address Republican concerns over the current user fee package that the Health, Education, Labor and Pensions (HELP) Committee marked up last month. HELP committee ranking member Burr said the new measure is a cleaner version of the earlier bill and removes a “partisan reconciliation package that includes devastating drug pricing proposals” that Senate Democrats added.

“Unfortunately, the user fee package reported out of (HELP) Committee would, if enacted, undermine the very purpose of the user fee program,” Burr said in a release. “The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation. In effect, this proposal would compromise the FDA’s overall ability to keep pace with advancements in the industry it regulates. And the Democrats’ recently released drug pricing proposal would further reduce private sector investment, making it more difficult for Americans’ to access new, lifesaving medicines.”

Earlier this month, commissioner Califf told the Alliance for a Stronger FDA that the uncertainty around the reauthorization hurts the agency’s staff recruitment and retention efforts. “Who wants to work in an organization if you’re afraid that these jobs are not even going to exist in the next short period of time?” he asked. “We really need to avoid that… If user fees are not funded, we’ll review products as quickly as we can, but the timelines go away and the commitment to the timelines goes away.”

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