FDA halts approval process due to government shutdown

California-based biopharmaceutical 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. The situation is however specific to allergy drugs due to the fact that congress must provide funding before the FDA is able to review allergy drugs.

Thus other pharmaceuticals already in the review process are not subject to the same restrictions. This is due to the fact that the approval process is funded by fees paid by those companies entering their drugs into the approval process in order for their drugs to be reviewed.

Meanwhile the FDA has said they can’t accept new applications during the shutdown, as around 40% of the understaffed agency’s workforce has been sent home. If the shutdown continues, the backlog of approvals may also cause delays. However the FDA has announced that they will resume inspections of high risk food processing plants.

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