Drugs

Election Year Will Affect FDA Actions: Attorneys

Hogan Lovells attorneys Lowell Zeta and Blake Wilson say actions that FDA will and will not take this year will vary in part because this is a presidential election year. Zeta and Wilson were joined by Greenleaf Health executive vice president for regulatory compliance Kalah Auchicloss and executive vice president Wilson Bryan, both former FDAers, on a panel at the recent J.P. Morgan Healthcare Conference.

Zeta discussed recent safety concerns related to CAR-T therapies and the overall benefit/risk profile, and how FDA’s approval of the first CRISPR gene editing therapy can be a helpful precedent for other gene-edited technologies in the pipeline.

Wilson questioned the quality of the safety data for novel regenerative medicines under the Accelerated Approval Pathway. “I’m not sure that the agency has figured out any sort of standardized approach to accelerated approval,” he said, suggesting that there may be an increasing variance among Centers and review divisions over clinical program design, evidence generation, and oversight of confirmatory studies.

Given the prevalence of industry noncompliance with confirmatory studies and the length of time it takes FDA to withdraw a failed drug, Auchincloss said the agency may need to reconsider its approach to how products are removed from the market when they are launched under accelerated approval and confirmatory studies do not produce the results that were anticipated.

Discussing FDA efforts to regulate laboratory-developed tests (LDTs), Auchincloss predicted the agency will continue to push toward final rulemaking in April, since it generally does not issue significant rulemaking late in an election year and likely will focus on implementation of agency-wide reorganization commitments. Wilson added that Congress likely will not pass LDT legislation, especially after several efforts to pass the VALID Act stalled.

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