The reintroduced legislation becomes the latest effort by a governmental body to address a perceived lack of prescription drug competition.
On July 23, 2025, a bipartisan group of U.S. Senators reintroduced the Short on Competition Act aimed at reducing prescription drug prices by increasing competition in the pharmaceutical industry. The Act, introduced by Sens. Amy Klobuchar (D – MN), Dick Durbin (D – IL), Mike Lee (R – UT), and Chuck Grassley (R – IA), would grant the Secretary of Health and Human Services (“HHS”) new powers to address prescription drug shortages and a perceived lack of competition for particular prescription drugs.
Specifically, the Act would allow HHS to grant expedited reviews and inspections for prescription drugs when there is or likely to be a shortage. HHS would be allowed to temporarily import prescription drugs under the same circumstances. The Act would also allow HHS to permit the same speedy review and importation powers when there are fewer than five pharmaceutical competitors manufacturing a prescription drug that has been approved for at least ten years. It is not yet clear what steps HHS would need to take before granting or ordering expedited reviews, inspections, or temporary imports.
The introduction of the Act—the second such attempt by the same bipartisan group of Senators—comes amid congressional frustration with pharmaceutical companies and perceived elevated prices. It is also thematically consistent with recent executive actions intended to lower US patient prices, including (i) the Trump Administration’s May 12, 2025 executive order on “most favored-nation” (“MFN”) drug pricing, (ii) the Department of Justice (“DOJ”) and Federal Trade Commission (“FTC”) listening sessions scrutinizing competition practices in the pharmaceutical space, and (iii) the Food and Drug Administration (“FDA”)’s newly-enacted National Priority Voucher Pilot Program, which is intended to accelerate approval timelines for drugs that voluntarily comply with MFN pricing.
Key Takeaways
- Continued broad focus on competition in the sector. Even if the Act does not pass, the Trump Administration remains focused on a perceived lack of competition in the pharmaceutical sector. The FTC and DOJ remain focused on delivering on Trump’s goal to uncover perceived threats to competition in prescription drugs, and continue to pursue an administrative case against Pharmacy Benefit Managers.
- Continued specific focus on drug pricing parity. Both Trump Administrations have tried to lower prescription drug prices within the United States to the prices being offered outside of the United States. Pharmaceutical companies should be aware that lower pricing offered outside of the United States, even if those prices result from trade-related efficiencies, may be subject to heightened scrutiny by numerous agencies including the FDA, DOJ and FTC.
- Pharmaceutical companies face multi-pronged, complex regulatory landscape. As outlined above, the industry faces challenges on multiple fronts—including legislation, agency initiatives, and potential enforcement actions targeting a range of actors such as Pharmacy Benefit Managers, as well as structural protections of the patent system. Given the nature of these challenges, we expect that pharmaceutical companies will seek to develop a coordinated response to this multi-pronged and ever evolving and increasingly complex legislative and regulatory landscape.
Trainee Associate, Billy Liu, contributed to this blog.
