Drugs

Pazdur Mulls Accelerated Approval International Harmonization

FDA is considering changes to its accelerated approval program, such as international harmonization efforts to “strengthen this approval pathway by considering the differences between expedited programs, including recent innovation by international [regulatory health agencies] RHAs,” according to Oncology Center of Excellence director Richard Pazdur and two other CDER officials.

Writing in a 1/20 JAMA opinion piece, the FDA officials seem interested in the expiry periods (one or two years) that certain RHAs attach to their expedited approvals. For example, in the EU and UK, a “conditional marketing authorization (CMA)” expires yearly and must be renewed with an application and interim report on outstanding obligations submitted at least six months before expiration.

Pazdur et al note that the evaluation of each renewal application includes a risk-benefit assessment, and a review of the time frame for completing confirmatory obligations determined at the time of the CMA. The mean time from granting CMA until conversion to a standard marketing authorization in the EU is 3.5 years.

“The expiry periods for conditional and provisional approval programs place the onus of timely completion of confirmatory trials and verification of benefit on the applicant in the EU, UK, Switzerland, and Australia,” the authors write. This contrasts with expedited programs elsewhere that place responsibility on the regulatory agency, like FDA, to initiate a resource-intensive withdrawal process. “Overall, these time-limited approaches may limit public exposure to stale claims of effectiveness that cannot be expeditiously substantiated,” they contend. “Conversely, as reasonable trial completion times are often indication specific, flexibility may be necessary in implementing such postmarketing time limits.”

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