“Right to Try” Laws, autonomy and options?

The New York Times ran an article about the “trend” among states to adopt “right to try” drugs, which allow critically ill patients to try drugs that have not yet been approved by the FDA.  Patients Seek ‘Right to Try” New Drugs  reviews the issues presented by “right to try” laws. These “right to try” laws have been adopted in several states, according to the article, including Arizona, Colorado, Louisiana, Missouri and  Michigan. What is truly the goal of “right to try” laws? Get unapproved drugs into the hands of those who need them, or something more?

According to the article, the laws are really about autonomy and control over one’s final days.

The laws do not seem to have helped anyone obtain experimental medicine, as the drug companies are not interested in supplying unapproved medications outside the supervision of the F.D.A. But that seems almost beside the point to the Goldwater Institute, the libertarian group behind legislative efforts to pass Right to Try laws. “The goal is for terminally ill patients to have choice when it comes to end-stage disease,” said Craig Handzlik, state policy coordinator for the Goldwater Institute, based in Arizona. “Right to Try is something that will help terminally ill people all over the country.”

According to the article, 10 states are likely to take up “right to try” laws in the 2015 legislative session, with pre-filed bills in a few states so far. The article notes there are critics of such laws.   The federal courts have already weighed in on “right to try” laws,  with the case, Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach , 495 F.3d 695 (D.C. Cir. 2007) (cert. denied, 552 U.S. 1159 (2008)). The “right to try laws” do have some limits, which the article describes, using Colorado as an example

The Colorado law, which is similar to ones in other states, permits terminally ill patients who have exhausted their treatment options — including clinical trials — to obtain therapies that have passed at least the first of three F.D.A. investigation phases. The law does not require companies to provide the treatment, nor does it mandate that insurance companies cover it; the law also allows insurance companies to deny coverage to patients while they use drugs under investigation.

For those patients who are terminally ill, there is help under the FDA rules for them to get access to unapproved drugs.  “[T]he F.D.A. created a process for granting unapproved therapies to people with exceptional need. Called the “expanded access program” or “compassionate use,” the program … is [the] way for terminally ill people to request an unapproved therapy after they are rejected from clinical trials.” Criticism of the length of the FDA approval process isn’t new,  and even the “expanded access program” has critics, with an illustration provided in the article.

These “right to try laws” intend to speed up the process by eliminating the FDA involvement. “Once a physician and a patient determine that treatment is the right choice — and that other options have been exhausted — the pair approach the drug company for permission.”

So “right to try” laws appear to be one more effort to preserve autonomy and give terminally-ill patients more options for their care;  another tool in the tool chest that includes advance directives, POLST, PAD, and DNRs, to name a few.