The partial government shutdown is beginning to cramp the Food and Drug Administration’s ability to review new drugs, and those effects will only grow more pronounced if the shutdown continues to drag on.
Driving the news: Aimmune Therapeutics, a company that’s seeking approval for a new drug to help children with peanut allergies, said in a financial filing yesterday that the FDA won’t be able to review its product until the government reopens.
How it works: Aimmune's product is an outlier — the FDA can only review allergy drugs when Congress provides funding. For other types of drugs, pharmaceutical companies pay the FDA a fee when they submit new products for approval, and those fees fund the review process.
What’s next: Several drugs could be left hanging in the balance if the FDA reaches the end of that five-week "runway" and the government is still shut down, STAT reports.
On the bright side, the FDA will resume its inspections of high-risk food processing plants, using unpaid inspectors.
Go deeper: All the ways Americans are feeling the effects of the shutdown
Editors' note: This story has been updated to clarify that the FDA's review of Aimmune's product would not be covered by industry fees.
