Drugs

Improve Accelerated Approval Process: Califf

FDA commissioner nominee Robert Califf says he’s a “fan” of the accelerated approval process but wants to see changes to speed confirmatory trials to determine if therapies that are given accelerated approval deliver the benefit they claim. Speaking as a member of a panel on accelerated approval at the 1/9 UCSF-Stanford Center of Excellence in Regulatory Science and Innovation “Innovations in Regulatory Science” summit, Califf said accelerated approval was a topic of discussion in his meetings with many senators as part of the confirmation process.

“I believe Americans want access to beneficial treatments as soon as possible,” he said. “We need a way to quickly evaluate the success of drugs that get accelerated approval.”

Another panelist, FDA Oncology Center of Excellence chief of medical oncology Julia Beaver said accelerated approval has been a great success with oncology drugs, often because companies are required to have confirmatory trials well along before they receive accelerated approval.

GlaxoSmithKline chief scientific officer Hal Barron said accelerated approval has been one of the most important regulatory innovations in some time but more rigor is needed in confirmatory trials. “We need to do a lot more work on timing to speed those trials,” he said. Barron also noted the success in oncology drugs and said he would like to see more accelerated approvals in other disease categories.

Support for more efficient confirmatory trials also was voiced by BIO president Michelle McMurry-Heath. “This is not the time to retreat,” she declared. “We need to double-down and modernize evidence collection. This is the future. We need to know as soon as possible if the treatments are effective.”

Califf said that one of the most destructive things that can happen is to promise people you have a benefit when you don’t. “Industry needs to assure people that the studies will be done,” he said.

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