According to a story from apnews.com, President Trump signed the “Right to Try” bill passed by Congress into law on Wednesday, May 30th, 2018. During the signing ceremony, he was joined by several families and patients affected by rare diseases, include eight year old Jordan McLinn, a boy from Indianapolis that has muscular dystrophy. FDA Commissioner Scott Gottlieb was also in attendance despite that fact that the bill actually undermines the regulatory authority of the agency that he currently heads.
“Right to Try” laws are enormously popular across much of the country, and many states have passed their own version of “Right to Try.” However, these laws have drawn significant criticism from patient advocacy groups. In theory, “Right to Try” is intended to give patients who are out of approved treatment options and are unable to qualify for clinical trials an opportunity to try experimental treatments that could potentially save their lives. However, there is no stipulation that these treatments have to have any data proving they could be effective. Patient groups are concerned that desperate, dying patients could be exposed to substances that could worsen their disease, inflict pain, or hasten their death.
Another problem with “Right to Try” is that the laws do not require insurance companies to cover experimental drugs, require doctors to prescribe them, or require manufacturers to provide them. Without these stipulations, the laws are effectively toothless; some critics have called them “placebo legislation.”
The state goal of these laws also may be dubious. Supporters claim that it is difficult for very ill patients with rare or severe diseases to get access to experimental treatments, but this isn’t quite true. The FDA’s expanded access “compassionate use” program already allows for patients to try experimental drugs. This program has far more safeguards to protect patients and records show that 99 percent of applications for the program gain approval from the FDA. The process takes four days, but in emergencies, approval can be granted with a simple phone call.
All of these facts leaves one wondering what the true purpose of these laws are. Considering its support from libertarian groups and the Koch brother’s Americans for Prosperity, it may be that deregulation is the real goal of “Right to Try.” It certainly does not appear to be the well-being of patients.
