Drugs

Orphan Drug Designation Requests Much Higher

FDA’s Office of Orphan Product Development (OOPD) received 472 requests for orphan drug designations in 2015, five more than the record-setting 467 requests in 2014. Attorney Kurt Karst (Hyman, Phelps & McNamara), writing in his firm’s FDA Law Blog, says that OOPD “designated an amazing 354 products as orphan drugs,” about a 22% increase over 2014.

Karst notes that while the OOPD workload has increased considerably in recent years, its staff level and budget have remained relatively flat. “While OOPD is a pretty lean, mean, working machine,” he writes, “resources can be stretched only so thin. We’re already starting to see some of the strains of the increasing workload on OOPD.”

He notes that while OOPD usually sets an internal target date for responding to orphan drug designation requests at about 60-90 days from date of receipt, it appears that the target date is now around 90-120 days.

“Those folks in charge of the purse strings should really consider dedicating greater funding to OOPD,” Karst concludes.

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