FDA’s new safety mandates and its inability to hire staff have caused the Office of New Drugs to give managers discretion to miss PDUFA deadlines, according to BioCentury. The policy was issued to the agency staff in January, but not disclosed until now, although a delay is reserved for exceptional circumstances. Nonetheless, agency officials say more than 10 percent of its deadlines could be missed this year, the newsletter reports.

This will hardly please all those who are already unhappy with the FDA over its new-found emphasis on safety issues. On one hand, 10 percent may not seem like a big number. As The In Vivo Blog points out, the agency’s official commitment under the PDUFA agreement was to meet 90 percent of its deadlines anyway. On the other hand, the FDA has actually been closer to 100 percent much of the time, the blog notes.

Between the inspections controversy, implementing the FDA Amendments Act and the ironically named ‘Safety First’ postmarketing initiative, FDA “has more work on our plate than we can possibly accomplish,” Jenkins tells BioCentury. “We are having to prioritize. We are having to set aside some things, hopefully on a temporary basis, until we can get adequately staffed.”

For the moment, this may not make a huge difference industrywide, given that the number of drugs approved has been falling anyway. There were only 19 drugs approved last year, in case you had forgotten. But if pipelines were to suddenly bulge, the new deadline policy could quickly become an issue.

Hat tip to The In Vivo Blog