Center for Health System Sustainability

President Donald Trump has made lowering prescription drug prices a signature issue during both his administrations. Until recently, however, he had relatively little to show for it. During his first term, Congress did not enact major drug-pricing legislation, and his executive initiatives on drug importation, international reference pricing in Medicare Part B, and rebate reform in Medicare Part D were left unimplemented.

The second Trump administration has pursued a broader, more aggressive “most-favored-nation” (MFN) drug pricing agenda, seeking to peg US prices to international benchmarks and thereby import lower prices paid abroad. Its initiatives include the Global Benchmark for Efficient Drug Pricing (GLOBE) model and the Guarding US Medicare Against Rising Drug Costs (GUARD) model, mandatory MFN reference pricing models for Medicare Parts B and D, respectively; and the GENErating cost Reductions fOr US Medicaid (GENEROUS) model, a voluntary model for Medicaid.

Most public attention, however, has focused on voluntary bilateral agreements with 17 drug companies representing 86 percent of branded drug sales. Announced between September 2025 and April 2026, these agreements include price concessions, commitments to sell drugs through direct-to-consumer channels (such as the administration’s TrumpRx website), and investments in domestic drug development and manufacturing (exhibit 1).

The significance of these deals is disputed. The White House touts them as “the most significant actions ever taken” to lower drug prices. Critics, such as Senator Ron Wyden (D-OR), have called them “a sham that benefits pharmaceutical corporations while offering little to no savings to patients and their families.”

Factors influencing the timing of regulatory submission for new drugs across countries are poorly understood. We identified all new drugs approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) during the period 2014–18 and tracked their regulatory submissions to the US, the European Union, Canada, Japan, and Australia through 2022. We assessed whether disease area, orphan status, therapeutic value, market size, and launch price were associated with submission delays. The FDA received the highest proportion of first submissions (70 percent). Median submission delays ranged from zero months (FDA) to 18.5 months (Australia). The range of median regulatory review times was small (9.2–14.1 months) compared with the range of median submission delays. Drugs with moderate-to-high therapeutic value were associated with a six-month earlier submission time compared to drugs with low therapeutic value, on average. Higher-price drugs were associated with earlier submission, on average. Overall, cross-national differences in drug availability largely reflected differences in submission, not regulatory review, times. Although the US had greater and faster availability of novel therapeutics, the difference was smaller for drugs that offered moderate-to-high therapeutic value.

Question: How have medical device patents contributed to periods of market exclusivity on drug-device combinations?

Findings: In this cohort study of 331 drug-device combinations approved by the Food and Drug Administration (FDA) from 1986 to 2023, 1751 of 3241 individual patent listings were on the delivery devices of these products. Medical device patents extended periods of protection for 180 products (54.4%) by a median (IQR) of 7.5 (2.8-13.9) years, with most device patents failing to mention the active pharmaceutical ingredients in their claims.

Meaning: Patenting strategies on drug-device combinations may impede generic entry and keep prices high for patients and payers.

The Inflation Reduction Act (IRA) requires Medicare to negotiate prices for certain brand-name drugs with gross annual Medicare spending exceeding $200 million. Small-molecule drugs are exempt from negotiation for 9 years following US Food and Drug Administration approval and biologics for 13 years. The pharmaceutical industry, some members of Congress, and the Trump administration have argued that this difference prioritizes the development of biologics over small-molecule drugs and have proposed aligning the initial eligibility periods for both at 13 years.1,2 To inform these policy discussions, we compared the revenues earned by manufacturers after 9 vs 13 years on negotiation-eligible products from 2012 to 2022.

Trade-related tensions between the United States and China have escalated dramatically in recent months. Despite a tentative agreement in May 2025 (extended in August 2025) to reduce the size of newly imposed tariffs on both sides, geopolitical frictions remain. Among other implications, these tensions threaten the cross-border trade of medicines. China has long been a major global supplier of generic drugs and active pharmaceutical ingredients. In recent years, it has also emerged as an important player in new drug development — a field traditionally dominated by the United States and European countries. This shift has implications for global access to promising new medicines and presents challenges for U.S. regulators and policymakers.

More than 75% of cancer drugs are approved by the US Food and Drug Administration (FDA) through expedited regulatory programs,(1) the use of which often leaves clinical uncertainties that may arise from issues related to trial design, conduct, analysis, or reporting—such as unvalidated end points, limited long-term data, or approval based on a single trial—about drug efficacy and safety.(2) Communicating these uncertainties is important, as clinicians may otherwise be unaware and overestimate a drug’s benefits and underestimate its risks.(3)

Although the FDA describes these uncertainties in detail in its benefit-risk assessments,(2) these documents are not widely read by clinicians. Instead, clinicians often rely on journal publications and guidelines. It is unclear whether clinical trial uncertainties about newly approved cancer drugs are reported in these sources.