Ewha Law School
Jungwoo Kang
Bob Godshall, a Pennsylvania state representative, authored a ‘right to try’ bill that is currently under consideration. His personal experience of being diagnosed with multiple myeloma convinced him that all patients suffering from permanent diseases should have the right to try experimental medicines. Godshall was denied a bone marrow transplant but managed to get it after agreeing that he would not hold the doctors responsible in case he did not make it. Like Godshall, the advocates for the so-called ‘right to try’ have tried to enact legislation to let terminally ill patients access treatments that are not yet approved by the FDA.
Before the enactment of the right to try, patients had two choices when they wanted to get access to experimental drugs. One was to bring a clinical lawsuit. Patients, however, are often too weak to travel and hardly qualify the health requirements. Secondly, they could ask the FDA for ‘expanded accesses’ of drugs that are on the approval process. The FDA tends to approve all requests, but the procedure is complex and time-consuming, so doctors are reluctant to enter the process. Under the new laws, doctors, patients, and drug makers can avoid the long process but rather they can strike their own deals. As of April, 34 states have enacted such laws.
Kurt Altman, national policy adviser for the Goldwater Institute, which created the model legislation of the right to try, said the new laws return control of medical decisions “back to a local level”. The enactment certainly is welcomed by lots of patients and their families as it gives them one last chance to save their lives, However, some critics question whether the right to try laws can help patients rather than harming them.
Since the laws allow drugs that have completed the very first phase of testing out of three, there is not enough data to prove whether they are effective or, at least, safe. Patients could be put at serious risks of increased suffering or even death in worst cases. Dr. John Jenkins also argues that removing the FDA from the discussion can cause the possibility of medical fraud. As it is almost impossible to know the worst outcomes of these therapies at this early stage of testing process, it is inevitable that patients may not be able to make a fully-informed choice to get the unapproved treatment. It is also questionable whether the drug makers would be willing to provide the drugs. This is because once any unexpected impacts emerge, the companies’ reputation can be damaged. Moreover, the drugs might not be covered by insurance policies, then the patients would be left with huge financial burdens.
The right to try laws, however, are still gaining supports from many of the US citizens. Given the difficulty for the dying patients to participate in clinical trials or the FDA’s expanded use process, there are strong desires of those patients to try the last resort to save their lives. It seems arguments against the right to try laws cannot be convincing unless they can come up with strong justifications of the denial of the right against those who are so desperate to try the last resort that they can bear any consequences of their own choices.
References
Adriance, S (2014) Fighting for the “Right To Try” Unapproved Drugs: Law as Persuasion, 124 Yale L.J. F. 148, available at: http://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs.
Clayton, R. P. (2008) Live or let die: Will the courts recognize in terminally ill patients a fundamental right to choose non-FDA approved drugs or does the FDA’s stringent approval process carry sufficient merit? Indiana Health Law Review 5: 123-153
Darrow, J. et al (2015) Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs. New England Journal of Medicine. 372: 279-286, available at: http://www.nejm.org/doi/full/10.1056/NEJMhle1409465#t=article
Tedeschi, B. (2017) With patients demanding experimental drugs, ‘right to try’ is becoming the law of the land. STAT. available at: https://www.statnews.com/2017/03/23/right-to-try/?s_campaign=tw&utm_content=buffer6911b&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Yang, Y. T. et al (2015) “Right-to-Try” legislation: Progress or Peril? Journal of Clinical Oncology 33(24): 2597-2599
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This is a gut-wrenching topic. As a mater of fact, I wrote a piece about this issue a decade ago.
But as you rightly pointed out, you can’t really achieve what you want with a “right to try” law unless pharmaceutical companies are aboard.
Also, I wonder how these state laws can overcome the “doctrine of preemption” in the face of the federal Food, Drug and Cosmetic Act.
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Thanks for your comment. I just read your article in 2008. I find it quite surprising that the debate about the issue has such a long history, and the right to try finally has its chance to become laws in the States (even though it is unclear if the bill could successfully pass the legislative process..). The federal right to try bill has not gone further than the Committee review stage since it was referred to Subcommittee on Crime, Terrorism, Homeland Security, and Investigations on 3/2/2017. I reckon if it fails to pass the whole process of legislation, it is fairly possible the state laws would have hard times facing the preemption doctrine.
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