FDA Policy/General

HHS Steps on FDA’s Feet to Advance 2 Policies

In the final days of the Trump Administration, HHS is proposing two last minute policies affecting FDA that are intended to enhance transparency, efficiency, and reduce unnecessary regulation. The first policy requires more information to be made public on drug approval timelines, and the second provides waivers from premarket review requirements on certain devices when data show the reviews are unnecessary, delay bringing devices to patients, and increase health care costs without corresponding safety and efficacy benefits, according to HHS chief of staff Brian Harrison.

The policy announcements reportedly came as a surprise to FDA, indicating a frayed relationship between commissioner Stephen Hahn and HHS secretary Alex Azar and other administration officials (see earlier story). The announcement rattled former FDA commissioner Scott Gottlieb, who said on Twitter: “I've been disappointed to see HHS infringing on FDA’s public health prerogatives in the closing days of the administration. The way they’re pursuing these unilateral actions will have long-term consequences at a time when FDA’s stature is critical to seeing us through this [Covid-19] crisis.”

The first policy would require FDA to publish annually for each NDA/ANDA approved the total days that elapsed between initial submission and approval. The second policy aims to make permanent pre-market review waivers for seven Class 1 devices that were granted temporary waivers during the Covid emergency. It would also extend the waiver to additional 83 Class 2 devices. HHS is asking for public comments on the waiver proposal.

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