COVID-19: Pharma and life sciences face potential further delays as FDA postpones review meetings

Erin McCallister Senior Manager, Health Research Institute, PwC US April 10, 2020

The FDA has been postponing advisory committee meetings and, in some cases, canceling them, as the COVID-19 outbreak makes travel impossible for attendees and the agency focuses its attention on the pandemic. The delays coupled with other changes the agency has had to make are likely to mean missed approval deadlines for some new drugs or devices. The agency uses the meetings to seek expert advice on specific drug or device applications under review or to gain insight on more general topics such as clinical trial endpoints or safety issues.

On March 11, the FDA said that it was “canceling or postponing all non-essential meetings through the month of April” and that it would “reassess on an ongoing basis for future months.” The agency said it would explore remote meetings “where possible.”

As of April 7, the FDA had postponed six committee meetings planned for March or April. Among those, five were related to specific drug or device applications under review while two were for more general business matters.

The FDA has just one meeting on its calendar for May, which is related to general business and is slated for a teleconference. Another May meeting was canceled for reasons other than the COVID-19 outbreak. The agency has just one in-person meeting planned for June that has yet to be postponed.

HRI impact analysis

The FDA has been hyper-focused on addressing the COVID-19 pandemic, issuing a flurry of FDA guidance, emergency use authorizations and new pathways for drug development. Additionally, the spread of the virus has grounded agency staff, resulting in delays of foreign and US facility inspections.

The delay of advisory committee meetings is yet another interruption in the FDA’s general operations due to the COVID-19 pandemic that could result in delayed approvals for new drugs and devices.

An analysis by HRI found that in the past few years, the FDA has held a pretty steady menu of advisory committee meetings from March through May. During this period in 2018, the FDA held 19 total meetings, and 14 in 2019, suggesting that the pandemic may be making a dent in its productivity where new product reviews are considered.

However, an analysis of the number of new drugs approved during this period over the past few years suggests it may be too early to know whether these changes to FDA operations will result in a meaningful delay of product approvals.

The FDA has approved eight new drugs or biologics since March 1, excluding supplemental license approvals. All of these came in March, with none yet in April. This is fewer than the 14 approvals the agency granted in March 2019 and three during the first two weeks of April. However, in 2018, the FDA approved just 11 new drugs in all of March and April. 

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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