Drugs

WLF Urges FDA to Replace Guidances with Rulemaking

The Washington Legal Foundation (WLF) is urging FDA to replace all older guidances with formal regulations that undergo a notice-and-comment rulemaking process. “Perhaps more importantly, FDA should adopt a strict rule requiring that all draft guidances not adopted in final form within two years of initial issuance must be withdrawn,” the group said in 12/7 comments to the agency. The comments were in response to an agency request to “identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction” (see earlier story).

In its comments, WLF took aim at FDA’s use of guidance documents as an “often-inadequate substitute for notice-and-comment rulemaking. The result of that practice has been the development of an entire body of ‘regulations’ that has never been subjected to an adequate review process and, indeed, often remains in ‘draft’ form for years on end.”

Additionally, the group is critical of FDA’s routine statements that guidance documents do not operate to bind FDA or the public. But this contradicts other statements that such documents embody FDA’s “current thinking” on regulatory issues, and many agency enforcement staff regularly point to guidances as the basis for concluding non-compliance, it says. “WLF submits that FDA’s current heavy reliance on guidance documents (including ‘draft’ guidances) imposes excessive burdens on the regulated community.”

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