President Trump has signed the Right to Try Law which is now the law of the land, or is it?
This legislation, in theory, gives people diagnosed with a life-threatening illness who have exhausted all the FDA approved treatment options the ability to gain access to yet unproven and unapproved drugs without having to get the permission of the FDA.
What has been lost on many people is that the drug companies have excellent reasons not to provide and many will probably not provide their developmental drugs, despite this law. Drug companies are not under any legal obligation to supply an investigational drug, but they may be subjecting themselves to potential liability without any economic return, so why would they be willing to supply the drugs?.
The law does allow the drug companies if they are willing to supply it, the right to charge a patient the actual cost of the drugs, but the real cost of many of these developmental drugs, when made in small batches, can be prohibitive.
Additionally, Cancer ABCs also predicts that it will be hard, if not impossible, for many patients to find a doctor who will be willing to supervise and administer these unproven and unapproved treatments.
There are better alternatives that should be explored before anyone tries to take advantage of this new law.
1- First, do your research and find out if the drug is in a clinical trial which you can join.
2- Secondly, contact the FDA and see if the drug is already available through an existing FDA Expanded Access Program.
We seriously doubt that this legislation will have any impact on many patients.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.
One of our readers, Kurt has requested that I add the following information to this post. Thank you Kurt for your work. - Joel
FDA Expanded Access Program
Wikipedia on FDA Expanded Access Program
Right to Try Law Generally
Federal Right to Try Law
Text of Right to Try Law - H.R.878
Text of Right to Try Law - S.204
General Description of Federal Right to Try Law
The majority of states already have their own form of Right to Try legislation, with one notable exception being New York. In Utah, a recently passed law specifically addresses the right of terminally ill patients to try cannabis. However, because cannabis remains federally prohibited, even if a terminally ill patient has the “Right to Try” cannabis on the state level, they’re still in violation of federal law. The Right to Try
bill, recently passed by Congress, would change that. In addition to cannabis, MDMA and psilocybin could also potentially be used by ‘eligible patients’ since FDA trials of both substances meet the requirements set out in the federal bill.
What’s not clear is what illnesses qualify as life-threatening. Post-traumatic stress disorder, for example, could be argued to be life-threatening given the high rates of suicide among those who are diagnosed, but it’s up for debate. It’s likely that those details will be hammered out on a state by state basis in jurisdictions that have already passed their own version of Right to Try. The full title of the bill suggests as much stating, “in accordance with State law…”
However, in states that lack their own local provisions, the new bill appears to leave plenty of room for interpretation and a potential conflict with local drug laws.
Under the broad wording of the federal bill, no specific illnesses are mentioned. Instead, an ‘eligible patient’ is defined as, “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and Diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.”
Patients must also have exhausted all existing treatment options and must be unable to participate in the ongoing trials investigating the drug they want access to. Additionally, they must provide written consent from a qualified physician who does not stand to gain from the trial.