Last week the U.S. House of Representatives voted to pass S. 204, “right-to-try” legislation unanimously passed by the Senate last August, and yesterday, May 30, President Trump signed the act into law.
In late January, the President gave the experimental drug legislation a boost in his State of the Union speech, calling on Congress to pass the bill. After months of debate and several unsuccessful attempts to incorporate adequate patient safeguards, the Right to Try Act of 2017 has become law.
The right-to-try law allows terminally ill patients to request access to experimental treatments not yet having FDA approval from drug manufacturers, bucking the current clinical trials process and virtually eliminating regulatory oversight. Several patient and provider groups have expressed concerns about the legislation, noting the lack of important patient protections and the likelihood – importantly – that this new law will not actually result in an increased number of patients accessing experimental drugs. Why?
Because the FDA already approves over 99 percent of requests submitted through an existing compassionate use program for patients with terminal illnesses who cannot otherwise participate in clinical trials. Additionally, while the right-to-try bill eliminates the legal barrier for providers to endorse and patients to pursue non-FDA approved drugs, there are no requirements for manufacturers to grant the request or for payers to cover the treatment or the management of adverse side effects. And without the same rigorous oversight and reporting requirements that are required of clinical trials, stakeholders note it could take months before the FDA is aware of serious harms or death from these experimental therapies.
There are also concerns about the impact on clinical trials; manufacturers have expressed apprehension that the legislation will lessen patients’ incentive to participate in clinical trials, and that any appearance of an unexpected side effect outside of a trial could hurt the drug’s chances of approval and even stop a clinical trial in progress.
Currently 39 states have passed some form of right-to-try law, and physicians have seen some important legal protections. Providers are not required to help a patient seek access to investigational treatments, and are protected from legal action based on their recommendation regarding an investigational therapy.
ACCC will strongly advocate to monitor the effects of this new law on cancer patients and providers, and continue to support timely access to safe, effective therapies with appropriate patient safeguards.
