Government Shutdown Isn’t Delaying FDA Advisory Meetings

Posted by on October 9, 2013

According to drug and device manufacturers, the US government shutdown which began on October 1, 2013 isn’t preventing the Food and Drug Administration from having their scheduled advisory committee meetings this month.

As with several other government sponsored organizations, analysts believed that the shutdown would severely impact FDA’s panel discussions, postpone meetings and ultimately delay various anticipated product launches.

Approximately half of the FDA’s staff has been retained during the shutdown and the majority of those staffers have responsibilities that only utilize funds resulting from user fees paid by drug and device companies in exchange for performance goals. In contrast, the FDA noted that the government’s shutdown has impacted food safety, nutrition and cosmetics initiatives.

“Since the underlying activities and staff are paid for by a combination of user fees and appropriated funds, it is too early to predict the priorities and achievable workload of the retained staff,” the Alliance for a Stronger FDA, a group that advocates for FDA resources, said in a statement last week.

In October, there are nine advisory committee meetings scheduled. 

Next week, the Encdocrinologic and Metabolic Drugs Advisory Committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. View the meeting announcement HERE!

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.