What does Preamble of Short on Competition Act do?

This bill, formally titled '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,' aims to address issues related to drug markets. The bill proposes to allow for expedited approval of generic prescription drugs. It also proposes temporary importation of prescription drugs. These measures are intended to be implemented in situations involving marginally competitive drug markets and drug shortages.

What does SHORT TITLE. of Short on Competition Act do?

This bill is formally titled the Short on Competition Act.

What does TEMPORARY IMPORTATION OF PRESCRIPTION DRUGS. of Short on Competition Act do?

This section amends the Federal Food, Drug, and Cosmetic Act to establish a temporary importation authority for prescription drugs. The Secretary can authorize importation of a drug for up to 3 years if a drug shortage exists and certain conditions are met, including the drug being authorized in another country and the manufacturer intending to seek approval under section 505(j). The Secretary may deny importation if the drug is deemed unsafe or ineffective, or if authorization in another country has been rescinded. The section also addresses marginally competitive drug markets, allowing the Secretary to expedite reviews and authorize importation under specific circumstances. A marginally competitive market is defined as one where fewer than 5 drugs are commercially available for at least two consecutive months, the drug has been approved for at least 10 years, and all relevant patents have expired.

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Short on Competition Act

Last updated: 7/17/2025 · Introduced: 7/17/2025

Author: Amy Klobuchar (D-MN)

TL;DR (AI)

The bill establishes a temporary authority for the Secretary to authorize the importation of prescription drugs to address shortages or marginally competitive markets.
It allows for expedited approval of generic prescription drugs to increase market competition.
The Secretary can deny importation if a drug is deemed unsafe or ineffective, or if authorization in another country has been rescinded.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

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