President Donald Trump called on Congress to pass right-to-try legislation. According to reports, the right-to-try’ legislation that aims to help terminally ill patients access experimental therapies and drugs that have not been approved by the Food and Drug Administration outside of clinical trials, was passed through the Senate and is now undergoing disputes from doctors, ethicists, and lawyers.
The medical providers and supporters who strongly oppose the bill argue that giving patients access to unapproved, experimental drugs risks possibly harming patients’ health, safety, the chance for survival and quality of life as well as give patients and families a false sense of hope. The letter requesting the government not to pass the legislation was published by Alison Bateman-House, associate professor of medical ethics at NYU Langone Health, and supportive colleagues.
Reports outlined that in the letter, the group of 336 academics said FDA approves more than 99% of expanded access requests “within a few days or even hours” and that the agency identifies changes in 11% of approved expanded programs that are necessary to adequately protect patients. They also noted that a 2017 Government Accountability Office report stated that no substantial changes were needed for the program, recommending only that FDA provide greater clarity on the use of safety data from expanded access programs.
