summary
Introduced
03/16/2023
03/16/2023
In Committee
03/16/2023
03/16/2023
Crossed Over
Passed
Dead
01/03/2025
01/03/2025
Introduced Session
118th Congress
Bill Summary
A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages.
AI Summary
This bill, the Short on Competition Act, aims to address drug shortages and marginally competitive drug markets. It does this by:
1) Allowing the Secretary of Health and Human Services to authorize the temporary importation of certain prescription drugs for up to 3 years if there is or is likely to be a drug shortage, as long as the imported drug meets certain conditions, such as having the same active ingredient as the drug in shortage.
2) Defining a "marginally competitive market" as one where fewer than 5 approved versions of a drug have been commercially available for at least 2 consecutive months, and the original drug was approved at least 10 years prior and has no remaining patents. In such cases, the Secretary can expedite review of applications and authorize temporary importation of the drug.
3) Requiring the Secretary to report annually on the number of drugs authorized for temporary importation under this new provision.
The goal is to enable quicker access to generic drugs and imported drugs when there is limited competition in the market for certain prescription medications.
Committee Categories
Health and Social Services
Sponsors (4)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 03/16/2023)
Bill Topics
Health
- ‐ Regulation of Drug Industry and Pharmacies
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/118th-congress/senate-bill/845/all-info | 03/17/2023 |
| BillText | https://www.congress.gov/118/bills/s845/BILLS-118s845is.pdf | 04/04/2023 |
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