Ex-FDA chief says regulator needs to up pace on COVID-19 drugs

Gottlieb
Scott Gottlieb (Francis Ying/KHN)

Scott Gottlieb has called on the FDA to deploy regulatory tactics honed on rare and deadly cancers to help get a treatment for COVID-19 to market by the summer. Gottlieb thinks the industry needs to hit that timeline if the U.S. is to both restart its economy and avoid a new epidemic in the fall.

With even the most optimistic forecasts suggesting limited availability of vaccines this year, drugs are the best hope of fighting back against SARS-CoV-2 in the near term. Recognizing that, Gottlieb, a former commissioner of the FDA, wants government and industry to go all in on getting a therapeutic to market by the summer. 

Writing in The Wall Street Journal, Gottlieb sketched out how the FDA could use approaches such as real-time reviews, which enable the regulatory evaluation of data from ongoing clinical trials, to cut the time it takes to get drugs against COVID-19 to patients. 

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The FDA has honed these approaches in recent years to accelerate the development of treatments for rare diseases, meaning it has the tools in place to speed COVID-19 drugs to market. However, the FDA may also need a clear signal of political support for the use of the tools. 

“FDA’s senior career scientists need the firm backing of political leadership to apply these and similar scientific approaches to COVID-19,” Gottlieb wrote.

Gottlieb sees two pools of products that could, with the benefit of a regulatory fast track, come to market in the summer. Gilead’s remdesivir is leading one of the pools, which consists of repurposed antivirals. Remdesivir has shown potential in preclinical studies and compassionate use cases and is at the head of the race to market.

Yet, Gottlieb’s op-ed spends more time discussing the antibodies in development. Those assets are less advanced than remdesivir, with Regeneron aiming to be in humans in June, but as an established approach to treating and preventing infectious diseases antibodies are seen as a very promising way of getting a handle on COVID-19.

The timing of the first approvals matters. As Gottlieb notes, while a combination of the current social distancing efforts and higher temperatures could see COVID-19 cases slump over the summer, people will remain concerned about a resurgence in the fall. An effective drug could help change that, enabling the U.S. economy to get back into gear without risking a second epidemic. 

With Kevin Warsh, a former Federal Reserve governor, estimating the availability of a drug against COVID-19 could restore $1 trillion in economic activity, Gottlieb wants government and industry to do whatever it takes to get such a medicine to market. 

“It’s time to place some firm bets and put resources behind these experimental treatments,” Gottlieb said.

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