Jan 12, 2018
Freedom Partners and AFP Memo: Right to Try is Not “False Hope,” It’s Common Sense
Post by Freedom Partners
Arlington, VA – On the heels of a digital campaign urging Congress to act on Right to Try, Freedom Partners and Americans for Prosperity issued a memo today responding to concerns from House Energy and Commerce Committee Chairman Greg Walden on the need to the act on federal Right to Try legislation for fear that state Right to Try laws may not be “used very much” and that federal Right to Try laws may provide terminally ill patients with “false hope.”
The memo argues that Chairman Walden’s concerns actually underscore why federal Right to Try legislation is so urgently needed. Freedom Partners Senior Policy Adviser Alan Nguyen and AFP Federal Policy Analyst Michael Lambert explain, “A lack of efficacy at the state level doesn’t preclude the need for federal legislation; it underscores the need for federal legislation. It’s precisely that lack of clarity at the federal level that’s hindering the efficacy of state-level efforts.”
While some claim that the FDA’s compassionate use program is working because it is granting access to experimental medications for 99 percent of patients who request it, a closer look at the numbers shows why that statistic should be a red flag that the system is broken.
“Though the FDA boasts of granting over 99% of expanded access requests it receives, it only received 1,757 requests for expanded access in total last year, minuscule in comparison to the 596,000 Americans who died of cancer in 2015, the 155,000 who died of chronic lower respiratory diseases, or the 111,000 who died of Alzheimer’s. This number is troubling in light of the nearly 26,000 patients receiving experimental treatments in France in 2016 under a similar program, meaning nearly fifteen times as many patients receiving experimental treatments in a country one-fifth the size.”
“The fact that so few compassionate use requests make it to the FDA for final approval is not an indication that terminally ill patients aren’t interested in trying these medications, it’s an indication that the process is broken.”
Furthermore, the lack of clear federal guidance produces a chilling effect that discourages drug companies from giving access to experimental treatments for fear of federal liability – even in states that have passed Right to Try laws.
“Without clear guidelines on how the FDA will respond to adverse effects of experimental treatments and the potential for federal liability, drug manufacturers are taking on significant risk. The net effect is a regulatory regime in which medical professionals and drug manufacturers are disincentivized by federal ambiguity despite overwhelming support at the state level.”
The bottom line is that federal Right to Try legislation would empower terminally ill patients and their doctors to pursue experimental medications and treatments that have passed Phase 1 of the FDA’s approval and remain in clinical trials when all other options have been exhausted. Right to Try is not “false hope,” it’s a last resort for individuals and families fighting to save their lives.
Currently before the House Energy and Commerce Committee, federal Right to Try legislation would allow terminally ill patients to access potentially life-saving experimental medication and treatment.
Federal Right to Try legislation would work with the FDA’s approval process to determine which experimental medications and treatments terminally ill patients could access, including only those that have passed Phase 1 of the FDA approval process and remain in ongoing FDA-sanctioned phase trials. Right to Try does not limit the FDA’s final approval process, but instead makes all terminal patients eligible to try drug and treatments available in clinical trials.