Dear Chairman Cassidy, Ranking Member Sanders, and Members of the Senate HELP Committee:
On behalf of the 60 Plus Association, I write to express serious concerns with three bills scheduled for markup on June 17: S. 2658, the Medication Affordability and Patent Integrity Act; S. 1954, the Biosimilar Red Tape Elimination Act; and S. 3014, the Ensuring Timely Access to Generics Act.
The 60 Plus Association is a non-partisan, non-profit organization committed to educating and advancing issues that matter most to seniors and their families. We support policies that lower healthcare costs, improve access to medicines, and encourage the development of new treatments and cures.
We are particularly concerned about the Medication Affordability and Patent Integrity Act (MAPIA). Supporters claim the bill would lower prescription drug costs by addressing alleged patent abuse. To accomplish that goal, the bill would create new certification, disclosure, and reporting requirements for biopharmaceutical companies to give patent regulators access to information already provided to the FDA.
Seniors deserve policies that are based on evidence, not assumptions. And supporters of MAPIA have yet to show that such abuse is a widespread problem in the first place. Americans already benefit from one of the strongest generic drug markets in the world. Roughly 90 percent of prescriptions today are filled with generic and biosimilar medicines.
The stakes are too high to get this wrong. Developing new medicines requires years of research and billions of dollars in investment. Investors are more likely to support those efforts when the rules are clear and predictable. Congress should not create new uncertainty unless it can demonstrate that doing so will produce meaningful benefits. Patients waiting for breakthroughs in Alzheimer’s disease, cancer, heart disease, and other serious conditions cannot afford policies that discourage the investment that makes medical progress possible.
The Biosimilar Red Tape Elimination Act is similarly bad policy. Biosimilars have helped expand access to lower-cost medicines and generated significant savings for patients. However, this bill would automatically deem all biosimilars interchangeable with their reference products, eliminating the FDA’s ability to make product-specific scientific determinations and potentially limiting FDA’s ability to approve more complex biosimilars.
Congress should not replace scientific judgment with a one-size-fits-all mandate. The FDA already has the authority to approve interchangeable biosimilars and is exercising that authority when the science supports it. As biologic medicines continue to evolve, the FDA should retain the flexibility to evaluate products on a case-by-case basis and require additional review when appropriate.
The Ensuring Timely Access to Generics Act is also troubling. Citizen petitions give patients, caregivers, physicians, and other stakeholders an important way to raise concerns with federal regulators. FDA already has the authority to reject petitions filed simply to delay competition, and the agency has reported no evidence that these petitions are delaying approvals. Congress should protect patients’ ability to raise legitimate concerns rather than restrict a process that is already subject to meaningful safeguards.
Seniors need affordable medicines, but they should not have to sacrifice future cures to achieve that goal. Congress can lower costs without weakening medical innovation or limiting patient voices. Lawmakers should focus on increasing transparency and accountability throughout the prescription drug supply chain, particularly among pharmacy benefit managers (PBMs), whose practices often drive up costs and prevent patients from receiving the full benefit of negotiated discounts and rebates.
We respectfully urge the Committee to reject S. 2658, S. 1954, and S. 3014 and instead pursue reforms that lower out-of-pocket costs, protect patient choice, hold healthcare middlemen accountable, and preserve the medical innovation that millions of seniors depend on today — and will depend on even more in the years ahead.
Sincerely,
Saul Anuzis
President
60 Plus Association
