Bill > S2345

This bill introduces two key mechanisms to address drug shortages and limited competition in the pharmaceutical market. First, it establishes a temporary drug importation authority that allows the Secretary of Health and Human Services to authorize the importation of prescription drugs for up to three years when a drug shortage exists or is likely. To qualify for importation, the drug must be legally marketed in other countries, have the same active ingredient as the drug in shortage, and the manufacturer must intend to seek FDA approval. The Secretary can deny importation if the drug is deemed unsafe or ineffective. Second, the bill creates a process for identifying "marginally competitive drug markets" by defining specific criteria, such as fewer than five versions of a drug being commercially available for at least two consecutive months, the drug being at least 10 years old, and all related patents having expired. In such cases, the Secretary can expedite review of drug applications and authorize drug importation. The bill also requires annual reporting on the number of drugs authorized for temporary importation. These provisions aim to increase pharmaceutical market competition and reduce drug shortages by providing more flexible pathways for generic and imported drugs to enter the market.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2345/all-info