Scroll
To Top

May. 22, 2018

TOPIC: Advocacy, Featured News

NORD Issues Statement Regarding House Passage of the Right to Try Act (S.204)

Posted by Christina Jensen
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.”

17 Responses to “NORD Issues Statement Regarding House Passage of the Right to Try Act (S.204)”

  1. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  2. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  3. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  4. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  5. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  6. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  7. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  8. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  9. […] Still, according to NORD, the Senate version that would later become the basis of the law — as opposed to an earlier House version — offered a troubling lack of protections. Specifically, the Senate version (S.204) failed to set a standard for informed consent, had a much broader defintion of eligibilty, and contained vastly weaker reporting requires, NORD said in a May 22 statement. […]

  10. Diane says:

    I’m a Grandparent of a rare disease called MPS-Hunter syndrome. No cure. My grandson Lukey is 4. He cannot walk..talk..play like other kids..I just wish & pray something could be done with finding a Cure..the average age that they live to be is usually in their teens.😧

  11. Harold B Noyes says:

    The case in England, where parents were prohibited from taking their child out of the hospital and out of the country for treatment, has everyone scared. How could this happen? It is morally wrong.
    I must agree with NORD, however, regarding the House of Representatives’ “Right to Try Act (S.204).”
    I have Marfan Syndrome (www.marfan.org), a rare disorder. I also have Tarlov Cyst Disease (www.tarlovcystfoundation.org), another rare disorder. I, like many in this country, want access to world-class, “cutting edge” (pun intended; 23 surgeries and counting!), and experimental (if necessary) treatments. However, I want some assurance that I know what I’m getting into, as far as risks and side affects are concerned. Since this bill 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”, I am opposed to it. Also, since it “contains vastly weaker reporting requirements”, any successes and/or failures will not be adequately recognized in a timely manner.
    Thanks to the people of NORD that continue to lobby for effective and needed reforms of the medical laws & regulations!

  12. […] some of their statement published last […]

  13. Mark Sliwicki says:

    I have Inclusion Body Myositis, and can’t assess to any treatment, now I have a chance.
    I hope now we get some cures instead of Drug treatments!

  14. Mary Pollock says:

    I lost my husband to Pulmonary Fibrosis in 2015, at the time of diagnosis there were no drugs /treatment for this awful disease. What is currently available is limited in its benefit. Please give these patients EVERY OPTION to extend their lives.

  15. ocie d alexander says:

    I was recently diagnosed with a rare disease called “Dercum’s Disease”. There is no treatment or cure known. Now that the House of Representatives signed Right to Try, S.204. I guess the chance for research on treatment and/or cure for this disease.

  16. cynthia S Chandler says:

    Please continue the fight. OUR government should be protecting and unifying the research community to find the best possible treatments for rare diseases. They should not vote in support of private corporate interests. Count me in to help with NORD’s effort!

  17. Donna Palita says:

    This bill will have to pass the senate to become law doesn’t it. I sent my rejection to the passage of this bill to DC. What would be the next step to stop this or is it too late.