The European Commission's new
action plan to combat antimicrobial resistance could further widen the
regulatory gap between the U.S. and Europe, which is already at the point where
some physicians worry companies will no longer seek FDA approval of
their antibiotics.
Indeed, the U.S. agency's
insistence on what companies and clinicians say are clinically irrelevant
endpoints has already resulted in one drug being approved in Europe this year
but not in the U.S. And FDA's requirements for what companies and doctors say
are unfeasible clinical trial designs have already lead some companies to wait
for the agency to change its tune before performing Phase III studies for U.S.
approval.