S. 2345 — Short on Competition Act

This section amends the drug shortage notification requirements under Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) to establish temporary importation authority for prescription drugs (i.e., those subject to section 503(b)(1)) that are in shortage or likely to be in shortage, as determined by the Secretary based on manufacturer notifications of supply disruptions or other information for critical drugs (i.e., life-supporting, life-sustaining, or for debilitating diseases, emergencies, surgery, or public health emergencies). Such authority applies for up to 3 years (or until the shortage ends) if the drug is lawfully marketed in specified countries (per section 802(b)(1), e.g., Canada), has the same active ingredient as the U.S. shortage drug, its foreign manufacturer certifies intent to seek U.S. generic approval under section 505(j), and an importer submits required attestations; importation must begin within 60 days of submission unless denied due to safety or effectiveness concerns. (Thus, this enables foreign versions of critical drugs to enter the U.S. market quickly during shortages, bypassing full FDA approval.) This section further adds Section 506C-2, directing the Secretary to treat a "marginally competitive market" for an "applicable drug" (i.e., non-radiopharmaceutical critical drugs) as a drug shortage solely for expedited review/inspection under Section 506C(g) and importation under new Section 506C(h); such a market exists if fewer than 5 approved drugs referencing the applicable listed drug (approved at least 10 years prior with expired active-ingredient patents) were commercially available for at least 2 consecutive months prior to determination (with only one drug per holder counting toward the threshold and considering discontinuations or non-competitive relevance). This section also requires the Secretary's annual drug shortage report to include the number of drugs authorized for temporary importation under Section 506C(h).