The Food and Drug Administration is getting stretched thin, with staff resources shifting toward COVID-19-related work. So much so, that the agency thinks it's possible it may not meet the goals set forth in the Prescription Drug User Fee Act (PDUFA), which establishes a time frame goal for the agency to make a decision on marketing applications for drugs.
"With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely. We anticipate that the New Drugs Program and the Biologics Program may need to allocate resources to focus on certain activities," the FDA wrote in a guidance document.
The FDA plans to give drugs for COVID-19 or certain other life-threatening conditions priority when resources are limited. While that certainly makes sense, it could delay the approvals of some me-too drugs.
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At this point, the agency is still listing the standard PDUFA goal date in letters to drugmakers -- eight months for a priority review and 12 months for a standard review -- and doesn't plan on extending currently established goals except for issues like Intercept Pharmaceuticals (NASDAQ: ICPT) experienced, where the biotech expects to have its approval delayed after submitting additional data to support the approval of obeticholic acid as a treatment for liver fibrosis due to nonalcoholic steatohepatitis.
For generic drug companies, the FDA is focusing on approvals for drugs for conditions for which there are drug shortages. The agency has been doing that for a while, but the pandemic could create some opportunities were new shortages result in generic drug companies jumping to the head of the line.
