FDA's on the air: Agency puts coronavirus front and center in podcast debut

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FDA Commissioner Stephen Hahn, M.D., stars in the agency's first "FDA Insight" podcast with a look at COVID-19 drug development. (FDA)

The FDA inaugurated its first podcast this week with an episode focused, not surprisingly, on coronavirus. Commissioner Stephen Hahn, M.D., joined host Anand Shah, M.D., the agency's deputy commissioner for medical and scientific affairs, to talk about development of drugs for COVID-19.

But industry veterans looking for clues on timelines for those meds—or details about FDA thinking on specific drug treatments—will likely be disappointed.

Shah described the podcast audience as mainly patients and consumers, and, to that end, the first episode focused on the basics of what the FDA does—and even explains healthcare terms used when discussing COVID-19, such as clinical trials, antivirals, investigational drugs and emergency use authorizations.

New episodes will drop every Tuesday with Shah, Hahn and other FDA leaders talking about a wide variety of issues, not just COVID-19. Topics will run the gamut of FDA oversight over what it estimates as 20% of consumer spending in the U.S.

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Shah and Hahn did briefly discuss Gilead Sciences’ treatment remdesivir, currently in use under an emergency authorization. Shah asked about the drug's promise as a treatment, but Hahn would only say that the FDA issued that authorization on the strength of early data from a U.S. National Institutes of Health (NIH) trial. The FDA will continue to review trial data as it's released, he said.

Underlining his consumer focus, Shah asked whether a patient could get remdesivir at a local pharmacy. "No," said Hahn. "This is not an outpatient drug at the moment. It is authorized for use in hospitalized sick patients.”

While Hahn pointed out 144 ongoing clinical trials in the U.S. for treatments to fight COVID-19, he called out no other drugs by name.

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Neither Shah nor Hahn mentioned the FDA's emergency authorization in March for hydroxychloroquine (HCQ), once championed by President Donald Trump. Last week, the FDA revoked HCQ’s clearance based on several studies that showed serious cardiac side effects and others that are potentially serious. The World Health Organization, HCQ maker Novartis and NIH all ceased hospital studies of the drug within the past week.

Nor did Shah and Hahn discuss vaccines during the relatively short 13-minute podcast, but Hahn did say those will be discussed in future episodes.