Short on Competition Act

More access to drugs in shortage

If enacted, the agency would be able to temporarily allow imports of foreign-made versions of U.S. drugs that are in shortage. The imported drug must have the same active ingredient and be lawfully sold in approved countries. The U.S. maker must certify it will seek U.S. approval and an approved importer must apply. The agency would generally decide within 60 days and could allow imports for up to 3 years or until the shortage ends. The bill would also let the agency call thin markets "marginally competitive" — when fewer than five competing drugs were sold for two months, the listed drug is 10+ years old, and its patents are expired — and treat them like shortages to speed reviews and imports. The agency could deny importation for safety or device concerns.