Short on Competition Act

Key Points

• The bill lets the FDA authorize imports of prescription drugs from countries with high safety standards when there is a drug shortage in the U.S. These imports can last up to 3 years or until the shortage ends, whichever comes first.
• It creates a new category called "marginally competitive drug markets" for drugs that have been approved for at least 10 years, have expired patents, but still have fewer than 5 competing versions commercially available for at least 2 consecutive months.
• When a marginally competitive market is identified, the FDA must treat it like a drug shortage, which triggers both expedited generic drug reviews and mandatory authorization of drug imports from approved foreign sources.
• Imported drugs must contain the same active ingredient as the drug in shortage and be lawfully marketed in an approved foreign country. The FDA can block any import it determines is not safe and effective.
• The bill has bipartisan support, introduced by Sens. Klobuchar, Lee, Durbin, and Grassley, and has been referred to the Senate HELP Committee. It also requires annual FDA reporting on the number of drugs authorized for temporary importation.