Drugs

OMB Calls for Enforcement ‘Best Practices’

The Office of Management and Budget (OMB) has given federal agencies until 11/26 to issue final rules needed to implement a 5/19 executive order setting forth 10 principles of fairness that agencies are to consider in administrative enforcement and adjudication actions. The order was issued to help promote economic recovery during the pandemic.

Attorneys Anne Walsh, John Fleder, and Robert Dormer (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that OMB expanded on the 10 principles by discussing “best practices” for federal agencies to follow under the executive order.

“So far, we have not seen any rulemaking from FDA that adopts these principles or best practices into FDA procedures,” the attorneys write. “Because the OMB deadline falls after the elections, it will be interesting whether FDA will follow these recommendations should there be a change in administration. But if FDA adopts these recommendations, it would go a long way to making FDA more transparent, fair, and accountable when opening and investigating conduct by FDA-regulated industry.”

After listing the 10 principles of fairness, the attorneys discuss some of the best practices that they would like to see FDA adopt, such as an expiration date and/or termination criteria for consent orders and decrees, a published rule of procedure for civil administrative inspections, and providing notice to regulated companies when an inspection is closed.

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