Key Takeaways
- •Sen. Bill Cassidy (R-LA) and Sen. Bernard Sanders (I-VT) debated competing strategies for drug affordability, contrasting market-driven biosimilar competition with government-led international price matching.
- •Brian Miller (Associate Professor, Johns Hopkins) recommended creating an abbreviated biologics license application pathway and a "behind-the-counter" pharmacist channel to lower costs and expand access.
- •Sen. Bernard Sanders (I-VT) pressed Ryan Long (Senior Research Fellow, Paragon Health Institute) on whether U.S. drug prices are the world's lowest, highlighting discrepancies in administration claims.
- •Republicans defended the Trump RX platform as a transparent market alternative, while Democrats criticized it as a limited gimmick that ignores more affordable generic options.
- •Future legislative efforts will likely focus on codifying FDA biosimilar streamlining and reforming the 340B program to prevent PBMs from prioritizing high-rebate, high-cost brand name medications.
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Hearing Analysis
Overview
This hearing focused on strategies to lower prescription drug costs for American families by fostering market competition, specifically through the expansion of generic and biosimilar medications. Lawmakers and witnesses examined the regulatory barriers at the Food and Drug Administration (FDA) that delay lower-cost alternatives, the role of pharmacy benefit managers (PBMs) in drug pricing, and the impact of international pricing models. The discussion highlighted a fundamental debate over whether to preserve current patent protections to incentivize innovation or to implement aggressive government interventions to ensure immediate affordability.
Key Testimony & Policy
Witnesses presented several concrete proposals to reform the pharmaceutical market. Dr. Brian Miller, a practicing physician and associate professor at Johns Hopkins University, advocated for an "abbreviated Biologics License Application" (aBLA) pathway. This proposal would apply the principles of the Hatch-Waxman Act to biologics, allowing biosimilars to gain approval based on pharmacokinetic data rather than expensive comparative clinical efficacy studies. Dr. Miller argued that 15 years of data prove biosimilars are as safe as originator products and that streamlining this process could reduce development time from nine years to just a few. He also proposed a "behind-the-counter" pharmacy channel to allow pharmacists to dispense certain medications without a physician's visit, citing successful models in the United Kingdom and Australia.
Ryan Long, a senior research fellow at the Paragon Health Institute, addressed the "rebate trap" created by PBMs. He explained that PBMs often exclude low-cost biosimilars from formularies because they do not offer the high rebates associated with expensive brand-name drugs. Long cited the example of Viatris being forced to launch two versions of the same insulin—one with a triple-inflated list price—just to secure PBM placement. He recommended codifying the FDA’s recent moves to eliminate switching studies for interchangeability and reforming the 340B drug discount program, which he argued currently incentivizes the use of expensive branded drugs over cheaper alternatives.
Robert Weissman, co-president of Public Citizen, testified in support of the Prescription Drug Price Relief Act, introduced by Sen. Bernard Sanders (I-VT). This legislation would prevent pharmaceutical companies from charging more for drugs in the U.S. than the median price in Canada, Britain, Germany, France, and Japan. Weissman cited Yale School of Public Health research estimating this would save Americans $184 billion annually. He criticized the current system as a series of "market failures" protected by 20-year patent monopolies and argued that the Trump RX platform is an ineffective "gimmick" that lacks generic options.
Notable Exchanges & Partisan Dynamics
The hearing featured a sharp divide over the effectiveness of the Trump administration's healthcare initiatives. Sen. Angela D. Alsobrooks (D-MD) and Sen. Edward J. Markey (D-MA) characterized the Trump RX website as a "scam," arguing it steers patients toward expensive brand-name drugs like Airsupra while ignoring $40 generic alternatives. Conversely, Sen. Ashley Moody (R-FL) and Sen. Jim Banks (R-IN) defended the platform as a transparent, market-based alternative that bypasses "rigged" PBM systems to offer direct-to-consumer discounts on 80 major drugs.
A significant portion of the Q&A focused on the role of the FDA. Chairman Bill Cassidy (R-LA) and Sen. Susan M. Collins (R-ME) discussed the abuse of "citizen petitions" by brand-name manufacturers to delay generic entry. Dr. Miller suggested that the FDA should have the authority to dismiss frivolous petitions and refer bad actors to the Federal Trade Commission (FTC) and Department of Justice (DOJ).
Partisan lines were also drawn over the Inflation Reduction Act (IRA). Democrats, including Sen. John W. Hickenlooper (D-CO) and Sen. Tammy Baldwin (D-WI), praised the law's Medicare price negotiation provisions, while Republicans expressed concern that undermining intellectual property would stifle future cures. Sen. Banks (R-IN) raised national security concerns, noting that 42% of drug licensing deals now come from China. Dr. Miller warned that if the U.S. does not modernize its "artisanal" FDA review process, China will dominate the life sciences industry, leaving American patients as "second followers" for new treatments.
Organizations Mentioned
- Food and Drug Administration (FDA): Discussed regarding its role in streamlining biosimilar approvals, managing citizen petitions, and the need to modernize its review process using AI. - Centers for Medicare & Medicaid Services (CMS): Mentioned in the context of Medicare drug price negotiations under the Inflation Reduction Act and the impact of Medicaid cuts on drug access. - Trump RX: A direct-to-consumer drug platform praised by Republicans for transparency and criticized by Democrats as a limited "gimmick" that lacks generic options. - Federal Trade Commission (FTC): Identified as a necessary enforcement partner to investigate pharmaceutical companies that use anti-competitive tactics like frivolous citizen petitions. - Yale School of Public Health (Yale): Cited for a study estimating that pegging U.S. drug prices to international levels would save $184 billion annually. - Paragon Health Institute: Represented by witness Ryan Long, who provided analysis on PBM reform and the 340B program. - Public Citizen: Represented by witness Robert Weissman, who advocated for bold systemic reforms and criticized the current patent monopoly system. - Express Scripts: Mentioned regarding its PBM practices and a recent FTC settlement concerning formulary access for low-cost products.
What's Next
Chairman Cassidy highlighted several pending bills for committee consideration, including the Ensuring Timely Access to Generics Act and the Biosimilar Red Tape Elimination Act. Sen. Margaret Wood Hassan (D-NH) and Sen. Jim Banks (R-IN) signaled interest in closing loopholes regarding the expiration of market exclusivity. Lawmakers also indicated a continued focus on PBM transparency, following the recent signing of the PBM Reform Act. Future oversight is expected regarding the FDA's implementation of new guidelines that eliminate comparative clinical efficacy studies for biosimilars.
Transcript
The Senate Committee on Health, Education, Labor, and Pensions will please come to order. When on the campaign trail, you talk to voters, and one thing that comes through is that life is too expensive. And they're struggling on how do they pay for gas, groceries, and healthcare. And in some things, I see healthcare is more than the other two. My experience as a physician working in a hospital for the uninsured and underinsured, it just brings back those memories of people struggling to pay for that which they otherwise couldn't. To that end, I announced a healthcare affordability plan earlier this week focused on making healthcare less expensive. The MVP plan, money in advance to bring value to patients. But there is a real urgency. The focus of this hearing is how do we make prescription drugs affordable to the American family. So let's start with what works, generics. About 90 percent of all drugs dispensed in the U.S. are generics, and they are affordable. In 2024, generics generated roughly $450 billion in savings. No other country has a generic system that works as well as ours. No other system develops as many new cures as the U.S., but the cures can be expensive and stretch or be beyond the budget of many families. Our goal should be to get these cures into a generic competition faster in a way that preserves the incentive for the next cure to be developed. Many of today's most innovative cures are biologics rather than traditional drugs. They have their own generic equivalent called a biosimilar. They're more complex and more expensive, not as simple as your blood pressure or high cholesterol drug. But they're life-changing. While biologics only account for about five percent of all prescription drugs in the U.S., that five percent makes up almost half of all prescription drug spending, and that is what is driving cost. We need to find a way that supports innovation and protects patients from unreasonably high prices, and both are possible. My goal is to take the lessons learned from generics and apply it to the biosimilars market to bring down the price of these biologics for Americans. We created the regulatory framework for biosimilars before we even had one on the market. The first biosimilar was approved in the U.S. in 2015, five years after the law passed. It's time for us to update that law. It's a complicated market. It has many competing factors, but we need to get patients what they need at the lowest possible price. This committee has taken steps to make both generics and biosimilars less expensive. The Ensuring Timely Access to Generics Act, the Biosimilar Red Tape Elimination Act are great bills I am working to make into law. And we need a free market approach. Ranking Member Sanders will speak, but he'll suggest undermining the free market by eliminating patent protections. But intellectual property protection incentivizes and rewards ingenuity and drives the work needed to find treatments and cures. Government overreach will harm Americans in the long run. When I was a doctor in L.A., 26 years old, and all those 26-year-old men were dying from HIV before we even had a cure, it was the ability to innovate that brought cures. And people who, once those cures became available, a diagnosis which had been a death sentence no longer was, and people lived long and full lives. I've seen personally in my practice the necessity and the power of innovation. Now, it is true that a lot of the research on prescription drugs is done by the NIH. But in most cases, this is the basic research. The pharmaceutical companies are the ones identifying practical applications for the research and doing the clinical trial. Crediting the NIH with developing prescription drugs is like saying the Defense Department supported the creation of the internet, therefore they created Amazon. No, Jeff Bezos, an innovator, created Amazon. Now, Republicans oppose eliminating patents. Intellectual property is key to incentivizing innovation and therefore having these life-changing treatments. The FDA has taken recent steps to streamline regulatory requirements and to incentivize biosimilar drug development. Their changes to guidelines are estimated to reduce the cost of certain studies by up to 50 percent, which decreases the costs for the developer and therefore for the patient. I'll note, this isn't the only way Republicans and President Trump are working to lower cost. Earlier this year, President Trump signed a PBM Reform Act, which we negotiated together on this committee, into law to increase transparency into prescription drug transactions and to crack down on the middlemen profiting from our purchases of these drugs. We're taking the right steps. The Trump administration is doing their job. This committee has worked together to define solutions. We need to keep doing so. I thank the witnesses for being here and look forward to speaking with you all as to how we can support the administration's efforts to lower drug prices and to make healthcare more affordable for American families. With that, I recognize Senator Sanders.
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