Drugs

‘Rigorously Scrutinize’ Accelerated Approval Program: Kumar

University of Illinois at Chicago psychiatry professor Anand Kumar says FDA should “scrutinize the accelerated [approval] program rigorously to ensure that surrogate endpoints are clinically meaningful before approving drugs under this mechanism.” Writing in an online opinion column for The Hill, Kumar traces the history of the accelerated approval program to 30 years ago when it was intended to accelerate drug approval in select life-threatening cases, like HIV, where the standard approval process was too long and cumbersome.

“It was predicated on the assumption that the surrogate endpoint would be demonstrably linked to relevant clinical outcome measures,” Kumar writes. “As the link between the surrogate marker and clinical outcomes becomes more tenuous, the process falls apart and becomes a mechanism for an end-run around the regulatory pathway. Enthusiasm and expedience should not replace scientific objectivity.”

He points out that FDA currently approves more drugs through this and other related fast-track mechanisms than the traditional route. “Approximately 75% of the drugs currently greenlighted by FDA participated in at least one special program designed to speed up the review process,” Kumar writes.

He says that while the program has had a positive impact on HIV and cancer chemotherapy, the concern is that the surrogate endpoint does not always predict clinical utility. And, he says, post-approval monitoring has been inconsistent.

“These drugs, at times, stay on the market despite failure to convincingly demonstrate efficacy in Phase 4 trials as ‘dangling approvals,’ drugs for which prior authorization continues in spite of lack of clinical efficacy,” Kumar writes. “In the interim, they cost the public billions of dollars and raise unrealistic expectations for treatment.”

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