FDA Policy/General

House Health Subcommittee Hearing on User Fee Agreements

The House Energy and Commerce Committee’s Health Subcommittee is holding a user fee reauthorization hearing 2/3 at 10:30 a.m. The hearing will review the reauthorization legislative language for the Biosimilar User Fee Amendments of 2022, Generic Drug User Fee Amendments of 2022, and Prescription Drug User Fee Amendments of 2022.

Noticeably absent at the hearing is the user fee agreement for medical devices, to which negotiations between FDA and the device industry have not concluded (see earlier story). The two parties have reportedly come to a standstill in their negotiations and remain about $1 billion apart in their proposals. They have reportedly not had talks since Thanksgiving, according to a report by Market Pathways. Once a deal is reached on device user fees, the commitment letter is posted for a 30-day public comment period and public stakeholder meeting must be convened before it can be sent to Congress.

The device industry is calling for a “back to basics” approach that is intended to provide enough funding and staffing to support FDA regaining pre-Covid-19 performance levels, but shying away from funding any new significant programs or initiatives tied to user fees. Meanwhile, the report says the agency is pushing hard for its TPLC (Total Product Lifecycle) Advisory Program (TAP) proposal, which would dedicate additional user fee funding to launch a concierge-style approach for participating devices. The two sides are also divided on how FDA handles carryover funds that are left over at the end of each fiscal year.

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