S 2345119th CongressIntroduced

Short on Competition Act

Introduced: Jul 17, 2025

Economy & TaxesHealthcare

Standard Summary

Comprehensive overview in 1-2 paragraphs

The Short on Competition Act would create new tools to address prescription drug shortages and limited competition. It adds a temporary importation authority for certain prescription drugs for up to three years if a shortage is anticipated or exists, provided specific safety and regulatory conditions are met. It also creates a new mechanism to identify and treat “marginally competitive” drug markets as shortages, enabling faster generic approvals and automatic authorization to import under the same temporary framework. Additionally, the bill would require annual reporting on drugs authorized for temporary importation. In short, the bill aims to reduce shortages and boost competition (and potentially lower prices) by expanding import options and accelerating generic review in markets deemed not adequately competitive.

Key Points

1Temporary importation authority (new 506C(h) in FD&C Act):
2- Allows importation of a drug for up to three years if a shortage exists or is likely, under conditions including: (A) the drug is a qualifying prescription drug, (B) it is lawfully marketed in approved countries listed by the bill, (C) the imported drug shares the same active ingredient as the U.S. shortage drug, (D) the manufacturer will seek approval under 505(j) (a subset of generic approval), and (E) an importer files attestations and identifies the drug and supplier.
3- Importation would begin no later than 60 days after the required information is received.
4- The Secretary could deny importation if the drug is not safe/effective, if used with an unsafe device, or if marketing authorization in partner countries has been withdrawn for safety concerns.
5- The importation authority would terminate after three years or when the shortage ends, whichever comes first.
6Marginally competitive drug markets (new 506C-2):
7- If the Secretary determines a marginally competitive market exists for a drug, that market is treated as creating a shortage for purposes of existing 506C provisions, and the Secretary may:
8- Expedite review of applications and inspections related to the drug, and
9- Authorize importation under the temporary framework.
10Criteria for determining marginally competitive markets:
11- The market must have: (1) fewer than five commercially available listed drugs referencing the applicable drug for at least two consecutive months before the determination; (2) the listed drug was approved at least 10 years earlier; (3) all patents claiming an active ingredient of the listed drug have expired.
12- “Commercially available” is defined with conditions such as discontinuation or withdrawal signaling non-availability, or other reasonable factors showing lack of market competition.
13Applicable drug scope:
14- Applies to drugs that are not radio-pharmaceuticals or other specially designated products.
15Annual reporting:
16- Updates to the FDA’s annual drug shortage reporting to include the number of drugs authorized for temporary importation under 506C(h).

Impact Areas

Primary group/area affected- Patients and healthcare providers: potential faster access to needed medications during shortages; could influence drug prices and availability.- FDA and drug importers: new regulatory pathway and oversight for imported drugs; added reporting requirements.- Generic drug manufacturers: potential expansion of expedited review in marginal markets and clearer paths to supply when competition is limited.Secondary group/area affected- Domestic brand-name manufacturers in affected markets: could face increased competition from imported generics.- International pharmaceutical suppliers and regulators in countries listed as eligible import sources: increased demand to supply U.S. shortages.Additional impacts- Public health and safety considerations: imports require assurances of safety and efficacy, with potential added post-market surveillance and risk management.- Market dynamics and pricing: expanded competition in marginally competitive markets may influence prices and availability, with short-term relief possible for shortages.- Legislative and regulatory workload: expanded responsibilities for the FDA, including eligibility determinations, expedited reviews, and annual reporting on temporary imports.503(b)(1) and 804(a)(3): references to regulatory categories for drug applications and products; 503(b)(1) generally relates to certain new and existing drug approvals, while 804(a) concerns importation and related authorities. The bill uses these to define which drugs qualify for temporary importation.505(j): the section governing ANDA (abbreviated new drug applications, i.e., generics).506C(g)/(h): sections of the Federal Food, Drug, and Cosmetic Act governing expedited approvals and temporary importation related to drug shortages.Listed drug: an approved drug that a generic manufacturer may reference when seeking a generic version under an ANDA.

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