This piece was originally published in The Hill.
Early last year, an FDA advisory committee rejected a new lung cancer drug. The reason? They weren’t too keen on foreign clinical data.
Later in the year, the developer of a potential variant-proof COVID-19 treatment that might even be effective against other viruses faced the same problem. The FDA rejected authorization, partly because none of the nearly 2,000 clinical trial patients were treated in the U.S.
The FDA’s increasing tendency to follow data only up to the water’s edge, a kind of “data nationalism,” may harm American health and future pandemic preparedness. It causes delays in drug approvals, increases the cost of drug development, and denies patients access to potentially life-saving treatments.