What is The Right to Try Act? Rebecca Braun

It’s never a situation we plan to be in, but have you ever wondered what your options would be if you were diagnosed with a terminal illness? Unfortunately, many people are faced with this reality and up until last year, were often told there were no options. However, the Right to Try Act may have changed this for some individuals. In this blog post I will discuss the new law, how it could affect terminally ill patients, and how to ensure that your wishes are honored through an updated patient advocate designation (medical power of attorney).

History of the Act

On May 30, 2018, President Trump signed into law US Congress Senate Bill 204, known as the Right to Try Act. This law is designed to give terminally ill patients who have exhausted all other treatment options the choice of whether they would want to try an experimental drug which has not been approved by the FDA.

Prior to this law coming into effect only certain states allowed this type of use of non-FDA approved treatments. Often, terminally ill patients are not candidates for treatment trials, so they were being denied access to potentially beneficial drugs. The Right to Try Act (Section 561B of the Federal Food, Drug, and Cosmetic Act) created a Federal law requiring all States to allow access to potential breakthrough medications for terminally ill patients who meet certain qualifications. The Act was designed to expand the scope of individual liberties, giving patients the right to choose whether they are willing to take the risk of an unapproved treatment, if it may mean a better outcome for their condition.

Who Qualifies and What is a Qualifying Treatment Under the Act?

The Right to Try Act permits or allows eligible patients to have access to eligible investigational treatments. An eligible patient is a patient who has:

  • Been diagnosed with a life-threatening disease or condition. Life-threatening disease or condition is defined under Federal law as: “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted” (21 CFR 312.81);
  • Exhausted approved treatment options;
  • Is unable to participate in a clinical trial involving the eligible investigational drug. This must be certified by a physician who is in good standing with their licensing organization or board and who will not receive compensation directly from the manufacturer of the drug; and
  • Has provided, or their legally authorized representative (Patient Advocate or Guardian) has provided, written informed consent regarding the eligible investigational drug to the treating physician, An eligible investigational drug is a drug:
  • Is the subject of an active investigational new drug application; and
  • For which a Phase 1 clinical trial has been completed;
  • That has not been approved or licensed by the FDA for any use;
  • Which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval or licensure;
  • Is the subject of an active investigational new drug application; and
  • Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA.

Ensuring Your Wishes are Honored

Whether you think you would want to try an experimental treatment or not, its important that your wishes are communicated. If you were to become incapacitated and no longer able to make treatment decisions for yourself, your patient advocate would do this on your behalf. Since the enactment of the Right to Try Act, we have included a section in our patient advocate document addressing this important issue. It allows you to state in writing whether you would want your patient advocate to consider experimental treatment options. Without providing this direction, your patient advocate may not know what you would want in such a situation. We believe that making your wishes known and ensuring you have properly drafted power of attorney documents is the most important piece of any estate plan. If you do not have these documents or would like older documents reviewed, please contact our office for a free telephone consultation. I will personally review your documents and give you an honest assessment of whether the documents will meet your needs.