The U.S. Senate just passed a bill that if it becomes law would codify Right-To-Try as a federal law, meaning terminally patients across the U.S. could ask their physicians and drug manufacturers to be given still investigational therapies such as still unproven stem cell therapies in development. The bill’s official name is
“The Trickett Wendler Frank Mongiello Jordan McLinn,and Matthew Bellina Right to Try Act of 2017.” Its goal is summarized this way, “To authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.”
It has 7 key bullet points according to the Senate:
It is the sense of the Senate that section 561B of the Federal Food, Drug, and Cosmetic Act, as added by section 2—
(1) does not establish a new entitlement or modify an existing entitlement, or otherwise establish a positive right to any party or individual;
(2) does not establish any new mandates, directives, or additional regulations;
(3) only expands the scope of individual liberty and agency among patients, in limited circumstances;
(4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food and Drug Administration;
(5) will not, and cannot, create a cure or effective therapy where none exists;
(6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk of mortality, and use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk; and
(7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients.
Proponents say it makes good sense and is ethical that such extremely ill patients should be given the right to try a wide range of options including unproven therapies, while opponents say it is too risky and that the FDA’s current compassionate use/expanded access program already works for such patients. It is likely that this bill will become law soon.
For two strong opinions either way on Right-To-Try see this debate from this week involving Beth Roxland of NYU and Christina Sandefur of the Goldwater Institute.
What do you think of the idea of a federal Right-To-Try law? Take our poll above.
I’m still not sure how I feel about this. BUT….I did a lot of research into these issues when Oregon passed the RTT bill about 2 years ago, and one thing is definitely true: in the past, the FDA had a terrible history of transparency when it comes to the question of who gets compassionate use, how they get it, and why it did or didn’t happen.. From all available information, it seems that it was all about who you knew, whether or not you were sophisticated enough to cut through red tape, if you had the influence to pull strings, etc etc etc. There was zero transparency. (I still have all of the references and sources that I found.) And I have to say that I think the longstanding issues with access have had a lot to do with why RTT was and is so appealing. People who had to go through the process had very little reason to trust that the FDA could handle fair access to whatever experimental treatments were available. This issue really needs to be openly admitted at this point.
Have great hopes this works for all
This sounds like a step in the right direction, however, it would not benefit people, such as myself, who suffer with ms because, for the most part, ms is a non life threatening disease.
Cathy, here’s the hope for those with non-terminal illness like MS. There are also terminal autoimmune illnesses like System Juvenile Rheumatoid Arthritis. There are a few children who’s lives have been saved using high dose expanded stem cells, which were extracted from their own fat tissue. RTT can make it easier for terminal patients to access therapies like this, thus growing the evidence base faster. And once the evidence is there that it puts terminal autoimmune patients into remission, the logical next step is to accelerate access and approval for chronic patients. I know this, because I had the same treatment for long standing MS, and have been im remission since 2014. We’re going to get there!