Dr. Aaron S. Kesselheim, Editor-in-Chief of The Journal of Law, Medicine, and Ethics, spoke before the House Ways and Means Committee on April 8, 2025 about the biosimilar market, as well as the effect of the devastating cuts the Trump administration has made to research and the NIH. Below, read his opening statement; you can watch the full hearing on YouTube.
Chairman Buchanan, Ranking Member Doggett, and Members of the Committee. I’m Aaron Kesselheim and I lead the Program On Regulation Therapeutics And Law at Harvard Med. Biosimilars are an important tool to help promote affordability and access for patients to essential biologic drugs. I have some ideas for the committee about how to support the availability of these products, but before I do that, I first want to make sure that everyone listening to this hearing understands what is going on at Harvard and every other academic medical center around the country right now. Because of the shortsighted policies of the current presidential administration, scientific investigation at these institutions is being absolutely decimated. The cuts involve government scientists–the CDC has already lost 20% of its staff. They also involve research grants and contracts–since inauguration, the pace of federal funds awarded by NIH has fallen to less than half the level granted last year. The administration is trying to drastically reduce indirect research funding–by nearly $4 billion per year–to levels below what institutions require to conduct the scientific investigations necessary for medical progress. Reviews of future grants have been put on hold. Without warning, projects have been tossed aside, wasting years of investment and time, including clinical trials evaluating potentially transformative new therapies that are being delayed and shuttered, pulling the rug out from desperate patients who have nowhere else to turn.
This is a crisis of immense proportions because it is universally recognized–at least, outside of the Trump administration–that government-funded research is the engine of therapeutic innovation, and that the science performed by and funded by the NIH, CDC, and other government institutions will lead to the biologics and eventually biosimilars of tomorrow. Government funding has been linked to basically every new drug approved by FDA, and has been particularly influential in generating various transformative treatments for cancer and rare diseases and a cure for hepatitis C. Every gene therapy product approved by the FDA had its origins in academic laboratories funded by the NIH. Trials showing the effectiveness of PrEP for HIV were funded by CDC.
The pharmaceutical industry relies on government-funded research to do similarly essential product development work, but when fundamental studies are not funded, are cut or hampered by delay, we are killing the possibility of new drugs in the future. We won’t see the effects in the next week or next month, but the next generation will look back on this moment and ask us what we were doing while the Trump administration systematically disposed of thousands of research projects that could have helped patients.
In addition to the prospect of massive harm to future drug innovation, I also want to point out the more short-term catastrophe that will result when patients cannot access the existing drugs that they need. Biosimilars can help, but even more important is the continued vitality of the Medicare and Medicaid programs, which provide drug coverage for about 150 million people. Cutbacks planned for Medicaid programs will force states to severely restrict their drug coverage, which will inevitably lead to patient deaths. Legislation being considered by this committee to undercut Medicare’s drug price negotiation will make drugs less accessible. Practicing doctors across the country like myself are extremely worried that patients may not get the drugs that they need.
If you want to identify some potential avenues for policy reform that will bolster the biosimilar market, I recommend empowering the FDA to designate biosimilars as interchangeable with the original biologic and with each other when the evidence indicates that switching studies are not necessary. We need to give the US Patent and Trademark Office the authority and resources to be more discriminating in reviewing patents to help prevent biologic manufacturers from building massive patent thickets that block biosimilar entry, and then ensure that the USPTO can administratively review granted patents so that litigation isn’t necessary. Access to biosimilars would also be supported by federal actions facilitating the ability of pharmacists to automatically substitute interchangeable products, because many state laws limit such substitution. The committee might also consider changes to reimbursement rules, like allowing Medicare Part B to combine biosimilars into a single reimbursement code or preventing PBMs from offering confidential rebates for biologic drugs once biosimilar versions become available. Medicare drug price negotiation should also not stop when biosimilars are introduced, since competition and negotiation can work in sync to offer fair price reductions for patients.
