Why Don’t We Have Full Drug Reciprocity with Other Countries?

Posted on by John C. Goodman

According to one study, recognizing drug approvals by regulatory bodies in Canada and Europe between 2000 and 2010 would have given U.S. consumers quicker access to 37 “novel” drugs for which “no other FDA‐approved prescription medicine had the same mechanism of action,” including 10 drugs treating mostly orphan diseases “for which no alternative therapy was available in the USA.” Such recognition would have allowed U.S. consumers to access those drugs a median of 13.6 months earlier.

Jeffrey Singer, Cato

1 thought on “Why Don’t We Have Full Drug Reciprocity with Other Countries?”

  1. Excellent idea. One way to discipline ossified or recalcitrant regulatory bodies like the FDA is to force them to coordinate (compete?) with other regulatory bodies, like the European Medicines Agency. In addition to speeding access to drugs, this could also accelerate approval of biosimilars, generics, and other cost-saving drug innovations. Establishing coordination requirements with agencies of foreign countries without adding undue bureaucracy or jeopardizing US sovereignty will be tricky, but it is a problem worth solving.

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