May. 22, 2018
Posted by Lisa Sencen
Washington, D.C., May 22, 2018 – The National Organization for Rare Disorders (NORD), the leading independent nonprofit organization representing the 30 million Americans with rare diseases, issued the following statement following today’s passage of the Right to Try Act (S.204) in the House of Representatives:
“Today, the House of Representatives passed the Right to Try Act (S.204). We at the National Organization for Rare Disorders (NORD) are sorely disappointed that the House of Representatives has voted to send this legislation to the President’s desk.
We have strongly opposed all Right to Try legislation, as we do not believe that it will safely and genuinely increase access to investigational therapies outside of clinical trials. Unfortunately, this version of Right to Try, S.204, is particularly concerning.
S.204 is devoid of all patient protections that the House version of Right of Try, H.R.5247, added. S.204 does not set a standard for informed consent, has a much broader definition of eligibility, and contains vastly weaker reporting requirements. Thus, not only will this legislation be ineffective, as all Right to Try laws are, it will also present a danger to the many patients we represent.
Through its expanded access program, the Food and Drug Administration (FDA) already provides access to experimental therapies, all while keeping patient safety a top priority. We have often advocated to strengthen FDA’s expanded access program and, with the prospect of Right to Try becoming Federal law, we will only increase our efforts. While we are disappointed that Congress has decided to ignore patient safety concerns, we will redouble our efforts to educate the rare disease patient population about clinical trial participation and enrollment as well as expanded access.
The bill that passed the House today is dangerous, and we will do everything we can to protect our patients from unsafe and ineffective therapies.”