FDA Policy/General

‘Information Bottleneck’ Due to FDA Staff Cuts: Analysis

Attorneys Sarah Wicks and Anne Walsh (Hyman, Phelps & McNamara) say the recent and drastic reduction in force at FDA “is quickly becoming an information bottleneck — one that threatens to erode the transparency that stakeholders rely on.” Writing in their firm’s FDA Law Blog, Wicks and Walsh say that if access to critical regulatory documents continues to slow or stall, “the consequences could extend beyond inconvenience, ultimately impacting the ability of patients, providers, and developers to make informed decisions that affect public health.”

The attorneys say they have seen a significant slowdown in the availability of information the agency is required to produce under the Freedom of Information Act (FOIA). “As it relates to FDA,” they write, “FOIA serves as a vital tool for stakeholders — including patients, researchers, and regulated industry — to better understand the agency’s scientific, policy, and regulatory decision-making.”

The post says stakeholders are now seeing longer wait times for both requested documents via FOIA and proactive FDA disclosures like approval packages that are routinely posted online and are required by the FDA Amendments Act to be posted within 30 calendar days of approval for new products or within 30 days of the third FOIA request for the action package.

“In some cases,” the attorneys write, “previously routine postings are delayed or going unpublished altogether. We also have heard from the remaining FDA FOIA staff that it could be at least a month before they can even provide a new estimate for when to expect responses under pending FOIA requests. For those requestors who already have been waiting months (or even years) for FDA to provide the documents that FDA put on a ‘complex’ track, the staffing cuts are hugely disappointing. Although there are avenues for escalating or litigating unreasonable delays for responding to FOIA requests, it is difficult to see how these approaches will be effective as no one may even be available to respond to an appeal until the dust settles.”

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