Drugs

FDA Cutting Orphan Drug Designation Backlog

FDA has released its plan to eliminate the existing orphan drug designation backlog and ensure timely response to all new designation requests with firm deadlines. An agency news release (contains link to modernization plan) says the plan comes one week after commissioner Scott Gottlieb committed in Senate subcommittee testimony to eliminating the backlog within 90 days and responding to new requests for designation within 90 days of receipt.

The release says there currently are about 200 designation requests pending review. The number of requests has increased steadily over the past five years, it says. In 2016, the Office of Orphan Products Development received 568 new requests for designation, more than double the number received in 2012.

FDA says this move is the first element of several efforts under its Medical Innovation Development Plan to ensure that agency regulatory tools and policies are modern, risk-based, and efficient. Under the orphan drug plan, FDA says it will “deploy a Backlog SWAT team comprised of senior, experienced reviewers with significant expertise in orphan drug designation. The team will focus solely on the backlogged applications, starting with the oldest requests. The agency will also employ a new streamlined Designation Review Template to increase consistency and efficiency of its reviews. The program will also look to collaborate with the agency’s medical product Centers to create greater efficiency, including joint reviews with the Office of Pediatric Therapeutics to review rare pediatric disease designation requests.”

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