S 2345

The Short on Competition Act aims to address prescription drug shortages and limited competition by allowing the FDA to temporarily import certain drugs from other countries. Specifically, it enables the FDA to authorize the importation of drugs facing shortages or in marginally competitive markets, provided they meet certain criteria like having the same active ingredient as a U.S. shortage drug and the manufacturer intending to seek generic approval. The bill also creates a mechanism to designate drug markets as ‘marginally competitive’ if fewer than five companies are producing versions of a drug, and it includes provisions for expedited inspections and reviews in such markets. Finally, it mandates annual reporting on imported drugs.