Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win approval for an experimental peanut allergy drug, preventing the Food and Drug Administration from beginning review of the company's application.
Aimmune had moved quickly to file its application for the drug, called AR101, a day before large parts of the U.S. government shuttered due to a funding lapse. Even so, the FDA has now notified Aimmune it will not be able to initiate review of the drug, the biotech said in a regulatory filing Monday.
FDA review of drugmaker applications for most new product approvals is funded through industry user fees. Due to the shutdown, however, the agency has been unable to accept new fees, while other activities have been sharply curtailed. On Monday, FDA chief Scott Gottlieb tweeted that the regulator has about five weeks' worth of carried-over user fees to fund work by its centers for drugs and biologics.
