During a nearly two hour Senate Health, Education, Labor and Pensions (HELP) Committee hearing last week on how to make prescription drugs more affordable for families, lawmakers heard repeated testimony that while the United States leads the world in medical innovation, patients still struggle to afford medications, particularly newer, complex drugs used to treat chronic and life threatening conditions.
Witnesses noted that the challenge is not a lack of effective treatments, but a system that allows prices to remain high even long after drugs have been proven safe and widely used.
Senate HELP Committee Chair Sen. Bill Cassidy (R‑La.), M.D., opened the hearing by pointing to generics as a rare success story in U.S. health policy. Roughly 90 percent of prescriptions filled in the U.S. are generics, generating an estimated $450 billion in savings in 2024 alone, Cassidy said.
But the savings stop when patients need biologic drugs, which account for just 5 percent of prescriptions while driving nearly half of total drug spending. “That is what is driving cost,” Cassidy said, arguing that the U.S. should replicate the success of generics in the biosimilar market.
Biosimilars or lower-cost versions of biologic drugs have been slower to take hold. Although the legal framework for biosimilars was created years ago, the first was not approved until 2015, and adoption remains uneven.
Streamlining FDA rules without lowering standards
Several witnesses pointed to the U.S. Food and Drug Administration (FDA) regulatory requirements as a major barrier to biosimilar competition.
Brian Miller, M.D., MPH, MBA, a practicing physician and associate professor of medicine at the Johns Hopkins University School of Medicine, said that the U.S. has enough real-world experience to safely simplify biosimilar approvals. “We have 15 years showing that no biosimilar is less effective than any originator product,” Miller told senators, adding that current approval timelines average nine years and cost hundreds of millions of dollars.
Miller proposed creating an abbreviated biologics license pathway—similar to the one used for small‑molecule generics—that would rely primarily on pharmacokinetic data, with FDA retaining discretion to request additional studies when necessary. “Old drugs should be cheap,” he said. “No one pays $200,000 for a 20‑year‑old Honda Civic. That’s not a marketplace.”
PBMs and the ‘rebate trap’
Witnesses also described how current Pharmacy Benefit Managers (PBM) incentives can favor higher‑priced drugs over lower‑cost alternatives.
Ryan Long, J.D., director of congressional relations and senior research fellow at the Paragon Health Institute, explained that biosimilars often struggle for formulary placement because they cannot generate large rebates. “A lower‑priced biosimilar simply can’t compete with a higher‑priced drug offering a 60 or 70 percent rebate,” Long said, noting that some manufacturers have been pushed to launch artificially higher-priced versions of the same drug to gain access.
Recent bipartisan PBM transparency reforms, passed earlier this year, attempt to address this by delinking PBM compensation from drug list prices in Medicare Part D. Witnesses broadly agreed the changes are a step forward, but not a complete fix.
Over-the-counter and ‘behind-the-counter’ drugs
Another area of bipartisan interest was expanding access to medications outside the traditional prescription model.
Long highlighted the growing importance of over‑the‑counter (OTC) drugs, which he said already save the health care system roughly $176 billion annually by reducing physician visits and encouraging price competition. He urged Congress to continue supporting FDA pathways that allow safe prescription‑to‑OTC switches.
Miller went further, proposing a new “behind‑the‑counter” category in which pharmacists could dispense short courses of medicines without a doctor visit. Similar systems operate in the U.K., Canada, and Australia, he said, and could significantly cut costs while expanding access through community pharmacies.
Pricing power and patents
While there was agreement on boosting competition, witnesses diverged on how aggressively government should intervene in pricing.
Robert Weissman, J.D., co‑president of Public Citizen, argued that market forces alone cannot solve the problem. “The pharmaceutical pricing and development system in this country is broken,” he said, citing data showing that Americans pay three to four times more for brand‑name drugs than patients in other high‑income countries.
Weissman supported proposals that would cap U.S. drug prices at levels paid in countries like Canada, Germany, and Japan, backed by estimates of $184 billion in annual savings. He also criticized practices such as extended exclusivities and authorized generics that can delay meaningful competition.
In contrast, Cassidy and several witnesses warned against weakening intellectual property protections. “Protection incentivizes and rewards ingenuity,” Cassidy said, pointing to HIV treatments and other breakthroughs that emerged under the current system.
Areas of emerging consensus
Despite disagreements over pricing authority, the hearing revealed several areas of overlap:
- Faster biosimilar approvals through streamlined FDA requirements
- Reforms to PBM incentives that disadvantage lower‑priced drugs
- Limits on abuse of citizen petitions and patent tactics that delay generics
- Expanded use of OTC and pharmacy‑based access models