President Donald Trump signed an executive order on Tuesday that will delay Medicare price negotiations for small-molecule prescription drugs, a move that pharmaceutical industry advocates have championed but patient advocacy groups warn could reverse recent progress in controlling drug costs.
The order, titled "Lowering Drug Prices by Once Again Putting Americans First," instructs Health and Human Services Secretary Robert F. Kennedy Jr. to work with Congress to modify the Medicare drug price negotiation program established under the Biden administration.
Key Changes to Medicare Drug Price Negotiations
The executive order specifically calls for a four-year extension of the period during which small-molecule prescription drugs are exempt from price negotiations with Medicare. Under the current Inflation Reduction Act provisions, these drugs—which typically come in pill form and represent approximately 90% of medications currently in circulation—are not subject to the negotiation process until at least nine years after FDA approval.
Trump's order aims to eliminate what pharmaceutical industry representatives have labeled the "pill penalty"—the four-year difference between when small-molecule drugs and biologics become subject to Medicare price negotiations. The administration argues this change will promote innovation and investment in pill-form medications.
Within 60 days, HHS must propose new guidance to enhance the Medicare Drug Price Negotiation Program for 2028 and earlier implementation years, focusing on greater transparency, prioritizing high-cost drugs, and maintaining incentives for pharmaceutical innovation.
Industry Response and Policy Implications
Patient advocacy groups have expressed concern that the order could undermine recent progress in controlling prescription drug costs. Steve Knievel, a drug policy advocate at Public Citizen, warned that "further delaying Medicare drug price negotiation would lead to higher prices for patients and taxpayers, not lower ones."
"Empowering Medicare to negotiate drug prices is the only significant legislative measure taken to address Big Pharma price gouging in the last 40 years. Now Trump proposes to undermine that singular achievement," Knievel added.
The advocacy group Protect Our Care stated that "Trump just caved to Big Pharma—again," arguing that the order "gives drug companies four extra years to price gouge seniors."
Current Program's Demonstrated Impact
The Medicare Drug Price Negotiation Program has already yielded significant results despite pharmaceutical companies' efforts to block it through legal challenges. The Biden administration's initiative resulted in discounts of 38% to 79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
In its second cycle, 15 additional drugs were selected for negotiation, with prices to take effect in 2027. These drugs, used by approximately 5.3 million Medicare Part D enrollees between November 2023 and October 2024, represent $41 billion in gross covered drug costs—about 14% of total Part D spending.
The program is also expected to significantly reduce out-of-pocket costs for millions of seniors and people with disabilities, including through a new $2,000 cap on annual drug spending set to benefit 11 million enrollees in 2025, saving a projected $7.2 billion collectively.
Broader Healthcare Cost Control Measures
Beyond the changes to drug price negotiations, the executive order outlines several other initiatives aimed at addressing pharmaceutical costs:
- Within 180 days, the administration will develop recommendations to reduce and stabilize Medicare Part D premiums
- The order directs joint public listening sessions between HHS, the Department of Justice, the Department of Commerce, and the Federal Trade Commission to identify and address anticompetitive practices in the pharmaceutical market
- A review of the role of Pharmacy Benefit Managers (PBMs) and other intermediaries in the pharmaceutical supply chain, with a focus on promoting transparency and competition
Healthcare policy experts note that while the executive order lays out an ambitious agenda, implementing several key provisions will require collaboration with Congress, meaning immediate relief for high healthcare costs is unlikely.
The announcement comes amid the Trump administration's push to impose tariffs on pharmaceutical imports—a strategy that some experts warn could trigger drug shortages and potentially drive up prices, creating tension with the stated goals of reducing medication costs for Americans.
