FDA halts allergy drug approval process due to government shutdown

pharmafile | January 15, 2019 | News story | Research and Development Aimmune, FDA, Trump, governmetn, shutdown 

California-based pharma firm, Aimunne Therapeutics has been notified that due to the government shutdown, the US Food and Drug Administration (FDA) will not review the company’s Biologics License Application (BLA) for its investigational peanut allergy treatment, AR101.

As noted in the company’s financial filing published on January 14 2019, the FDA has indicated that it will not initiate the review until the government shutdown had ended, due to the fact that congress must provide funding before the FDA is able to review allergy drugs.

Nonethless, other pharmaceuticals already in the review process are not subject to the same restrictions due to the fact that the approval process is funded by fees which can be carried over from 2018.

“We continue to operate the programs using carryover user fees, and we’ll prioritize work that impacts public safety, as this is our foremost priority,” Scott Gottlieb, commissioner of the FDA said.

Meanwhile the FDA has said they can’t accept new applications during the shutdown, as around 40% of the agency’s workforce had been sent home. However January 15 saw 400 FDA staff return to their posts.

Nevertheless, if the shutdown continues, the backlog of approvals may still cause delays. “We expect drug manufacturers could face near-term regulatory gridlock and the potential for a backlog of delayed filings, meetings, and regulatory decisions that could extend even beyond the end of the shutdown,” RBC Capital Markets analyst Brian Abrahams said in a note. He added that Regeneron Pharmaceuticals and Celgene Corp could be among those adversely affected.

However the FDA has announced that it will resume inspections of high risk food processing plants, high-risk medical device manufacturing facilities, high-risk drug manufacturing facilities and high-risk biological manufacturing facilities as hundreds of staff return to work.

Louis Goss

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