When only a handful of companies make a generic prescription drug, supply can vanish for months and prices can spike. This bill would let the FDA temporarily approve imports of the same drug from other wealthy countries — for up to three years — whenever there is a shortage or whenever fewer than five generic competitors have been on the market for at least two months. The imported drug must have the same active ingredient and a manufacturer willing to seek full U.S. approval. The FDA can refuse imports it judges unsafe. Patients filling prescriptions for older off-patent medicines that have become hard to get would see more options sooner.
Congressional Summary
Short on Competition ActThis bill requires the Food and Drug Administration (FDA) to provide temporary authorization to import certain prescription drugs facing shortages or in a marginally competitive drug market.Specifically, the FDA must authorize importation of an eligible drug that is lifesaving, life-sustaining, or intended to treat or prevent a debilitating condition. To be eligible, a drug must (1) be facing a shortage, (2) require a prescription, (3) have received market authorization in certain foreign countries, and (4) have the same active ingredient as the drug for which there is a shortage in the United States. The drug's manufacturer must also seek approval for the drug as a generic drug.The authority to import a drug terminates after three years or when the shortage no longer applies, whichever occurs first. Importation must begin within 60 days of the FDA receiving an application that meets all of the applicable requirements. The FDA may deny importation of a drug for reasons related to safety or effectiveness.Drugs in marginally competitive markets must be treated as being in shortage for the purposes of this bill and may be treated as such for the purposes of expediting inspections and reviewing applications. A drug is in a marginally competitive market if (1) there are fewer than five holders of approved applications for commercially available brand-name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) the patents on the drug's active ingredients have expired.
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2025-07-17
- Date Added
- 2026-04-25
Like reading a bill in plain English?
We're building an app that does this for every bill in Congress and lets you tell your reps how you want them to vote. We're a small team getting ready to launch, and we're trying to show investors that real people want this. Be one of them. Help us get it built. Leave your email and we'll tell you the moment the app is ready.