FDA Policy/General

HHS Transparency, Fairness Rule

In one of its final actions in the last week of the Trump administration, HHS has issued a final rule it says is “designed to enhance HHS practices involving transparency and fairness in civil enforcement actions.” An HHS press statement (includes a link to the final rule) says the new final rule supplements and builds on the 2020 HHS Good Guidance Practices rule by setting out rules for appropriate HHS reliance on guidance documents and requiring the department’s agencies, including FDA, to give fair notice of relevant agency positions before taking civil enforcement action.

The statement says the final rule reiterates HHS’ commitment to proper use of guidance documents by generally prohibiting the department’s agencies from treating non-compliance with a standard or practice announced solely in a guidance document as itself a violation of law. The statement says the rule also lays out procedural requirements for HHS that are intended to ensure fairness in all civil enforcement actions. For example, agencies may only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise.

FDA has its own good guidance rules that must be revised to match the HHS requirements, according to the HHS document. However, observers have indicated that the incoming Biden administration is likely to withdraw the HHS final rule, eliminating the need for FDA to match it.

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

Read more

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