FDA Policy/General

HHS Good Guidance Rules Could ‘Ossify’ FDA: Analysis

HHS published 12/7 a rulemaking formally adopting good guidance practices (GGP) that are to be followed by all component HHS agencies, including FDA. Attorney T. Daniel Logan (Kleinfeld Kaplan Becker) outlines the impact on FDA, which has had its own different good guidance practices that were adopted 20 years ago to comply with requirements of the FDA Modernization Act of 1997.

Logan says the HHS and FDA regulations differ at the outset, with contrasting approaches to defining which agency documents constitute “guidance” for GGP. “The HHS definition of guidance appears to be broader than FDA’s definition and gives FDA less leeway to proactively determine that a document would not constitute guidance,” he writes.

The post also looks at procedural and political controls on guidance documents and petitions for review of guidance documents.

“By instituting procedural controls that differ from current FDA requirements, increasing political review of guidance on a non-delegable basis, and instituting a potentially onerous guidance petition process, the HHS GGPs, if fully implemented, have the potential to ossify guidance development at FDA,” Logan says. “Such a shutdown could make FDA less able to adopt new guidance or revise older guidance to respond to changing technologies, markets, or research. The GGPs also represent a clear step to remove some of FDA’s autonomy from HHS.”

The post notes that the incoming Biden administration would withdraw the Executive Order containing the GGPs, rendering moot the need for FDA to amend its regulations to match the HHS version.

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