Please ensure Javascript is enabled for purposes of website accessibility

FDA Says COVID-19 Could Delay Drug Approvals

By Brian Orelli, PhD – May 28, 2020 at 7:11PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The pandemic is pulling the agency in different directions.

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.

Pills on $100 bills

Image source: Getty Images.

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.

Brian Orelli has no position in any of the stocks mentioned. The Motley Fool recommends Intercept Pharmaceuticals. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/30/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.