Drugs

FDA to Explain Post-Health Emergency Effects

Ropes & Gray attorneys say FDA will publish a notice in the Federal Register explaining the effect the HHS decision to terminate its Covid-19 public health emergency (PHE) on 5/11 will have on FDA guidances and enforcement policies. In an online post, the attorneys say that at the outset of the emergency, FDA developed policies, often published as guidances, to help alleviate difficulties such as drug and device shortages and other supply chain pressures associated with the pandemic. The policies automatically expire at the end of the emergency.

“FDA has indicated that it does not intend all of its policies to be impacted in the same way by the end of the PHE,” the post says. The attorneys write that until FDA provides its clarification, the impact of the PHE termination on enforcement discretion policies can be understood as follows:

IVD Enforcement Discretion policies will not terminate with the end of the PHE. Entities that manufacture, sell, market, or distribute products affected by enforcement discretion policies relating to IVDs should watch for the FDA Federal Register notice.
Medical Device Enforcement Discretion policies relating to Covid 19 products will remain in effect only for the duration of the PHE. The attorneys refer stakeholders to their analysis of the FDA 12/2021 transition plan for medical devices that identifies policies that will terminate with the end of the PHE and has recommendations for a phased transition process for devices covered by such policies. They say the transition plan anticipates a 180-day buffer to permit manufacturers of certain medical devices covered by certain Covid-19 enforcement discretion policies to come into compliance with standard laws and regulations. They urge affected companies to begin reviewing and familiarizing themselves with the transition plan that will take effect on 5/11.
Covid-19 Operational Policies will terminate at the end of the PHE.

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