As your constituent and in alignment with the Hypertrophic Cardiomyopathy Association (HCMA), I strongly urge your support for critical legislative reforms to address systemic challenges to the quality, transparency, and safety of generic medications in the United States.

Generic drugs account for more than 90% of prescriptions filled in our country. While these medications are a vital, cost-saving component of our healthcare system, the current regulatory framework—heavily reliant on facility inspections rather than systematic, independent batch testing—has created significant, avoidable risks for patients.

The Challenge: A Market Lacking Transparency

Patients and clinicians frequently operate under the false assumption that all FDA-approved generic drugs are identical in quality, strength, and efficacy. In practice, however, current statutes, such as the Hatch-Waxman Amendments, focus on bioequivalence at the time of initial approval but do not require consistent, standardized dissolution rate measurements for all batches.

This oversight gap is particularly concerning given the globalization of the pharmaceutical supply chain. When products are manufactured overseas with limited oversight, inconsistencies in bioequivalence and dissolution rates occur, leaving patients without the medication quality their condition requires. For those managing complex, chronic conditions—such as hypertrophic cardiomyopathy—these variations can lead to severe adverse health events, unnecessary hospitalizations, and increased long-term costs to our already burdened healthcare system.

Patient-Centered Solutions:

To protect some of the most vulnerable Americans, we must transition to a system that prioritizes quality and transparency. We support:

The CLEAR LABELS Act – requiring prescription drug labels to identify where medications and active ingredients are manufactured.

The TraQ Pharma Act – expanding independent quality testing, supply chain risk monitoring, and transparency in pharmaceutical manufacturing.

The TraQ Pharma Act, while currently focused on medications purchased by the U.S. Department of Defense (DoD), can be implemented incrementally to include Medicare patients and the general public.

I urge you to take an active leadership role in advancing bipartisan legislation, making necessary updates to Hatch-Waxman, and to strengthen the quality, transparency, and security of the U.S. pharmaceutical supply chain. Supporting the Clear Labels Act and the TraQ Pharma Act is a matter of public health, an issue of national security, and a fundamental necessity for equitable healthcare.

The HCMA remains dedicated to partnering with your office to provide the real-world evidence and stakeholder insights necessary to advance this vital reform. We look forward to working with you to ensure that healthcare works for all your constituents and that every patient has access to safe, reliable, and high-quality medication. To schedule a convenient time to discuss how we can work together to accomplish this, please reach out to Julie Russo, HCMA Director of Legislative and Volunteer Programs, at julie@4hcm.org or call (973) 983-7429.

Thank you for your time and your commitment to this critical issue.