The Trump administration’s push for U.S. drug manufacturing is part of an overall shift away from foreign reliance for drug supply –– but the FDA has built a track record in the last few years of handling drug shortages with overseas regulatory lenience, according to a recent report from ProPublica.
The agency has allowed substandard factories abroad to ship medications to the U.S. despite manufacturing failures that would normally result in a ban. The agency exempted 150 drugs from import bans, mostly in India, and didn’t regularly test them or monitor problems reported by doctors, the report found. This week, ProPublica published that list of drugs for the first time, highlighting just how many medications have been affected.
The report also underscored the enormous challenge the FDA faces in monitoring foreign manufacturing facilities, but reshoring these facilities is also a massive undertaking. Today, we’re looking at one of the new programs from the FDA that aims to ease the process for building out new manufacturing facilities in the U.S.
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