Drugs

Firm Paid $2.5 million User Fee for Non-reviewed BLA

Aimmune Therapeutics mistakingly paid a $2.5 million user fee with a BLA submission for AR101, an investigational biologic oral immunotherapy for treating peanut allergy that was submitted just before the partial government shutdown. Under the agency’s shutdown guidelines, such a submission could have been accepted for review because the fee and submission were accepted before the shutdown began.

However, the company said 1/14 that it was recently informed that the submission would not be reviewed until the government shutdown and lapse in appropriations has ended. Speculation began that somehow the company was being wronged, and FDA commissioner Scott Gottlieb stepped in via Twitter to explain how such a scenario might have occurred without specifically addressing Aimmune’s predicament.

According to Gottlieb, “for products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications... The point here: User fee programs are operating. We’re still reviewing products submitted as part of user fee programs. But blood products and allergenic products are not covered by user fee programs. So routine review activity ceased related to new products in these categories.”

Gottlieb noted that sometimes companies will try to file under pathways that aren’t open to them. “Allergenic-type products only meet criteria to fall outside the allergenic category in very specific circumstances,” he said. “When confusion does occur by sponsors it’s highly unfortunate and we always try hard to provide clarification where appropriate. As a general matter, if all of a sponsor’s interactions are with the allergenic products division, it’s an indication that it’s an allergenic product.”

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