Over the past few years, legislation that would give terminally ill patients access to unapproved treatments, known as “Right-to-Try,” has gained momentum in a number of states and now in the U.S. Congress. As the organization representing the world’s leading clinical research organizations that each year conduct more than 7,000 clinical trials involving 1.3 million patients in more than 100 countries, is deeply committed to ensuring treatments are made available to patients in need, to the full extent possible, through the established clinical trials process in order to effectively monitor safety and efficacy. ACRO also supports measures to accelerate the drug discovery, development and approval process without sacrificing patient safety.
As such, ACRO’s view is that proposed Right-to-Try legislation is deeply flawed because it:
- contains insufficient patient protections;
- compromises the clinical trial process; and
- undermines the FDA’s authority to assess safety and effectiveness;
ACRO has significant concerns that including Right-to-Try provisions in the upcoming user fee reauthorization or any subsequent legislation would be detrimental to patients.
Read the full policy statement here.
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics, and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more than 130,000 professionals worldwide and conduct research in more than 100 countries. For more information, please visit www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel. Facebook. LinkedIn.