FDA Policy/General

DoJ Changes 2 Guidance Policies: Attorneys

Attorneys Anne Walsh and JP Ellison (Hyman, Phelps & McNamara) say the Department of Justice (DoJ) “quietly” changed the role of guidance documents by reversing two Trump administration policies on such documents. Writing in their firm’s FDA Law Blog, Walsh and Ellison say the first policy, from 2017, prohibited department components from issuing guidance documents that purport to create rights or obligations binding on persons or entities outside the federal government’s executive branch.

The second policy, known as the Brand Memo (written in 2018 by then-associate attorney general Rachel Brand) prohibited department lawyers from civilly prosecuting companies for violating “requirements” outlined in guidances.

Walsh and Ellison say a 7/1 memo signed by attorney general Merrick Garland said the policies were “overly restrictive” and hampered department attorneys when litigating cases where there is relevant agency guidance. Garland says department attorneys handling an enforcement action may rely on relevant guidances in instances when a guidance “may be entitled to deference or otherwise carry persuasive weight with respect to the meaning of the applicable legal requirements.”

Walsh and Ellison say that “in light of the seemingly renewed general focus on enforcement activities after a Covid-19 lull, regulated companies should anticipate the resumption of FDA inspections. In preparation, companies should consider whether new guidance documents have been issued that ‘require’ changes in business practices and documentation. Additionally, on the government investigation front, companies should expect that DoJ lawyers assessing potential False Claims Act cases based on alleged Federal Food, Drug, and Cosmetic Act violations, are reading FDA guidance documents with renewed vigor and contemplating how to use those guidance documents in their cases, which routinely result in multi-million dollar settlement demands.”

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