By: Devika Kandelwal
September 10 2020
In 2018, Trump passed the right to try which allows terminally ill patients to gain access to unapproved medications is still in development.
In 2018, Trump passed the right to try which allows terminally ill patients to gain access to unapproved medications is still in development. In May 2018, Trump signed into law legislation that allows terminally ill patients to seek access to experimental medicine that is not yet fully approved by the Food and Drug Administration. The bill allowed terminally-ill patients to bypass the FDA and obtain an 'investigational drug' with their doctors' approval if the drug manufacturer agrees to supply it. The bill's chief sponsor, Sen. Ron Johnson, a Wisconsin Republican, had described the bill as something that 'expands the scope of individual liberty' and provides 'hope for terminally ill patients who have nowhere else to turn.' The New York Times reported that the bill was opposed by many Democrats and by dozens of organizations representing patients, including the National Organization for Rare Disorders and the lobbying arm of the American Cancer Society. According to them, the right-to-try bill could greatly increase patients' likelihood of being harmed by unsafe and ineffective experimental therapies. Moreover, several former commissioners of the FDA and some clinical experts at the agency said that the bill was unnecessary because patients with serious illnesses could already obtain experimental medicines through a program known as expanded access or compassionate use. The then-FDA Commissioner Dr. Scott Gottlieb told Congress in October 2017 said that the FDA approves 99 percent of the requests it receives under this program. Still, in some cases, it recommends changes to protect patients before allowing the treatment to proceed. Furthermore, according to a policy report from Rice University, the Right to Try does not ensure that manufacturers will provide the drug or that insurance companies will cover the cost. Obtaining the medicines from manufacturers can be more cumbersome than going through the Food and Drug Administration's existing program, the report found. Colorado enacted the first right-to-try law in 2014. A 2017 study by researchers from New York University found that since then, 'there have been no documented cases of anyone receiving access, because of a right-to-try law, to an experimental product that would not have been available via the FDA's expanded access program.'