Legislation & Regulation

Legislation and Regulation in the U.S.

  About half of clinical trials take place in the United States—more than any other nation in the world. That’s why ACRO works with government agencies and policymakers to ensure a positive policy environment that advances and supports high-quality, safe, and ethical clinical research.

ACRO’s legislative agenda in the U.S. is focused on promoting policies that foster innovation in the drug development process and ensure that the U.S. remains a competitive venue for clinical trials. We consistently advocate for a better-funded, scientifically-advanced FDA as well as supporting Federally-funded medical research programs.

Our current legislative priorities include:

  • Lobbying to advance tax policies that recognize the critical role CROs play in research & development and ensure that the U.S. remain globally competitive
  • Working to integrate research applications into electronic health records (EHRs) to facilitate outcomes research and patient recruitment for clinical trials
  • Supporting the 21st Century Cures initiative launched by the House Energy & Commerce Committee.

ACRO and the FDA

ACRO supports a strong, robust FDA with expanded resources to ensure better control over the quality, safety, and efficacy of clinical trials and drug development in the United States. Specifically, ACRO:

  • Advocates for increased appropriations for the FDA’s international activities
  • Supports the FDA’s goal of bolstering its regulatory science capabilities
  • Meets with FDA officials to discuss an array of regulatory issues important to clinical research
  • Collaborates on special projects and initiatives that support innovation in the drug development process
  • Holds a seat on the Steering Committee of the FDA-sponsored Clinical Trials Transformation Initiative (CTTI)

Since ACRO’s founding in 2002, every FDA Commissioner has met with our Board of Directors, ensuring our efforts remain consistent with the Administration’s goals and objectives.

What Else We’re Doing

In addition to supporting a strong FDA with extensive oversight, ACRO also works with the following organizations, government bodies, and initiatives in the United States:

Read more about ACRO’s legislative and regulatory policy goals: