Expanding access to life-saving treatment
Posted on June 26, 2018 17:43 pm CDT
By Congressman Billy Long,
Over the past several years, 39 states have passed Right to Try laws, with Missouri being the third state to do so. These laws allow terminally ill patients, who have exhausted all other options, access to potentially life-saving treatments that are not yet available to the public.
Before Right to Try laws were passed, patients were left with few options, including clinical trials. A sad example of this is the number of cancer patients enrolled in clinical trials, which is less than 5 percent. Another option was the U.S. Food and Drug Administration’s compassionate use application process, which allows individuals to access treatments not yet approved by the FDA. What was intended to help patients access life-saving treatments turned into a process that was both expensive and time-consuming. Due to the complicated process, only about 1,200 people make it through each year.
Right to Try laws aim to help with this problem by expanding terminally ill patients’ access to investigational drugs not yet approved by the FDA. Last October, the Energy and Commerce Health Subcommittee, which I hold a seat on, held a hearing examining patient access to investigational drugs. This hearing was used to look at the FDA’s compassionate use application process, and legislation, such as Right to Try, that would build upon the FDA’s work and expand access even more for patients who have exhausted all other options.
In May, both the House of Representatives and Senate passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017. Soon after, President Trump signed the bill into law. S. 204 gives terminally ill patients expanded access to unapproved drugs through their doctors. This bill saves money and time for patients who sometimes have very little of either.
Along with increasing access to investigational drugs, S. 204 also has a number of provisions that protect patients. It ensures patients provide informed consent to use investigational drugs, guards patients from manufacturers who intentionally mislabel drugs and requires manufacturers to release annual reports on drugs that have not yet been approved.
After months of bipartisan work, terminally ill patients across the country will finally have more than just a few options. These men and women who are facing some of the toughest circumstances will now have a say in the care they receive. Moving forward, I plan to build on our work and continue to increase access and options to life-saving treatments.