On Monday, August 4, 2025, the Department of Justice (DOJ) and the Federal Trade Commission (FTC), in coordination with the Department of Health and Human Services (HHS) and the Department of Commerce (DOC), hosted a listening session titled Turning Insights Into Action to Reduce Drug Prices. As part of implementing President Donald Trump’s Executive Order No. 14273, Lowering Drug Prices by Once Again Putting Americans First, this was the final of three joint agency-led listening sessions focused on improving the affordability of prescription drugs through competition. Per the Executive Order, listening sessions will inform the joint report to be issued by October 12, 2025, on recommendations to address anticompetitive practices in pharmaceutical markets.
This session brought together leading Capitol Hill officials specializing in pharmaceuticals and intellectual property to discuss their perspectives on ongoing challenges and solutions to drug affordability and accessibility. Panelists touched on several policy challenges, including the U.S. patent system and potential abuses by drug manufacturers, challenges for generic and biosimilar market entry, vertical integration and consolidation, and pharmacy benefit manager (PBM) reform. A summary of key challenges and proposed legislative solutions from each speaker is highlighted below.
Franci Rooney Becker, Chief Counsel on the Senate Judiciary Committee to Senator John Cornyn (R-Texas)
Challenges Highlighted:
- The pharmaceutical and biotechnology industries have many opportunities for arbitrage, misuse, and bad behavior.
- Intellectual property needs to be protected while generic and biosimilar access to the market must also increase.
- The “patent dance” framework has not functioned as intended due to lack of trust and information sharing.
Proposed Solutions:
- Affordable Prescriptions for Patients Act: targets patent thickets in the context of the patent dance.
- Drug Competition Enhancement Act: addresses product hopping.
Thomas DeMatteo, Chief Counsel on the Senate Judiciary Committee to Senator Mike Lee (R-Utah)
Challenges Highlighted:
- Burdensome regulations have created red tape that often shields incumbents from generic competition, which has been intensified by the Affordable Care Act (ACA) rules.
- The entire healthcare system lacks price transparency and competition. A web of intermediaries (insurance, PBMs, wholesalers, pharmacies, etc.) prevent patients from having information about costs.
- While PBMs play a central role in negotiating substantial rebates and discounts that, in principle, could reduce system wide dug costs, they have become “toll collectors” along the drug supply chain, implementing rebate traps, benefitting from the Medical Loss Ratio rule, and engaging in a range of anticompetitive practices that artificially inflate drug prices and favor higher-cost brand drugs that provide higher rebates when alternative lower-cost drugs are available.
- Patents are essential for innovation, but they also create temporary monopolies that allow companies to charge higher prices and discourage biosimilar entry.
- Government-created artificial market constraints, such as Medicare setting reimbursement rates below market value, forces hospitals and pharmacies to shift costs to privately insured patients.
Proposed Solutions:
- Biosimilar Red Tape Elimination Act: makes FDA-approved biosimilars automatically interchangeable once deemed safe and effective.
- Short on Competition Act: allows the HHS Secretary to expedite reviews, inspections, and temporary importation in the event of a drug shortage. It also allows expedited review of drugs approved for more than 10 years with less than 5 suppliers.
- Remove government-imposed artificial market constraints.
J John Lee, Chief Counsel for Intellectual Property of the House Judiciary Committee
Challenges Highlighted:
- The “balance” and status quo are not fostering innovation and access.
- Patents are an important incentive, but they can also be anti-competitive and anti-innovation if clear limits are not enforced.
- Terminal disclaimer and skinny labeling issues delay biosimilar/generic entry.
- The pharmaceutical and biotechnology industries are very heavily regulated compared to many other US industries, and US consumers are disadvantaged by trade policies in other countries.
Proposed Solutions:
- Enforce clear limits of patent rights to prevent anti-competitive behavior and enable follow-on innovations.
- Support US Patent and Trademark Office (PTO) efforts on addressing litigation challenges and improving prosecution accuracy.
- Affordable Prescription for Patients Act: addresses patent thickets.
- ETHIC Act: prevents abuse of terminal disclaimers.
- Skinny labeling reforms.
Peter-Anthony Pappas, Director of Intellectual Property (IP) Policy for the US Senate Committee on the Judiciary under Senator Thom Tillis (R-North Carolina) – Chairman of the Subcommittee on Intellectual Property
Challenges Highlighted:
- Allegations about patent thickets and evergreening are based on misleading and debunked data, such as from I-MAK, which influences policymaking that does not address competition and reduces incentives for innovation.
- Proposals that target the patent system to lower drug prices often disregard the balance between innovation and access for generics/biosimilars. Patent settlements and diagnostic patents face unjustified legal certainty.
- PBMs are a primary source of blocking access to generics/biosimilars.
Proposed Solutions:
- Strengthen the patent system based on reliable data and facts to foster innovation and accessibility.
- Tillis requested the FDA and USPTO conduct a study on patent data, which refuted claims by groups like I-MAK.
- PREVAIL Act: restores balance regarding Patent Trial and Appeal Board (PTAB) proceedings and eliminate “gamesmanship” by bad actors.
- Encourage patent settlements that contribute to innovation.
- Reform PBM practices.
Nicholas Pottebaum, Health Policy Advisor to Senator Chuck Grassley (R-Iowa), Chairman of the Senate Judiciary Committee
Challenges Highlighted:
- Nearly 30% decline in retail, rural, and independent pharmacies in a decade.
- Lack of competition and abusive practices in supply chain.
- Lack of transparency in drug prices.
- Opaque, consolidated, and powerful PBMs that dictate drug accessibility, pricing, and reimbursement. A two-year bipartisan study on insulin price gouging found that PBMs were encouraging manufacturers to spike drug list prices for greater rebates.
Proposed Solutions:
- As passed in the Prescription Pricing for the People Act, the FTC should complete and submit its study on PBMs in a timely manner.
- PBM Transparency Act: stops deceptive and unfair pricing schemes like spread pricing and arbitrary clawbacks of payments and require PBMs to report revenues made from spread pricing and pharmacy fees.
- Ensure fair assessment of pharmacy performance fees and quality metrics under Medicare Part D to prevent spread pricing and PBM conflicts of interest at the expense of patients.
- Delink compensation from medication prices under Part D.
- Empower self-insured health plans with data from PBMs.
- Establish fiduciary duty of care standards for PBMs.
Peter Stein, Senior Policy Adviser to Congresswoman Diana Harshbarger (TN-01)
Challenges Highlighted:
- Brand manufacturers exploit lack of coordination between FDA and USPTO to submit information that leads to secondary patents and unfair patent thickets.
- Growing vertical integration of entities and a lack of transparency and data availability on contracting and arrangements.
- PBMs hold disproportionate market power, wield significant conflicts of interest, and engage in steering practices.
Proposed Solutions:
- Medication Affordability and Patent Integrity Act: requires manufacturers to certify consistency in FDA and USPTO filings, otherwise their patent could become unenforceable if found improper in later litigation. This legislation is expected to unlock more generic competition and save patients money.
- Lower Costs, More Transparency Act: helps address the growing vertical integration of entities in Medicare and other systems.
- Promoting Transparency and Healthy Competition in Medicare Act: improves public data reporting and transparency into how vertically integrated companies interact to better understand the impact of arrangements on delivery.
- PBM Reform Act: provisions include banning spread pricing in Medicaid, ensuring pharmacies are fairly and adequately reimbursed, adopting new Part D requirements such as delinking compensation from the costs of medications, price transparency in employer health plans, and allowing CMS to define and enforce reasonable and relevant Part D contract terms, including reimbursement.
- Patients Before Monopolies Act or the “PBM Act”: addresses conflicts of interest, prohibits parent company of PBM or insurer from owning a pharmacy business, or requires parent company in violation of PBM act to divest its pharmacy business within one year of enactment. There is strong precedent for this provision, including recent legislation in Arkansas, and support from 39 states and attorneys general who have called on Congress to take federal action to separate PBMs from pharmacy ownership.
