In early spring a bill that aims to give patients with terminal diseases the right-to-try drugs that have not yet been approved by the Food and Drug Administration was passed in the House of Representatives. Though the drugs that want to be tried by these severely ill patients have passed the phase 1 of the FDA process of inspection and testing, they are not available yet in pharmacies, because they haven’t passed phase 2 testing.
The right-to-try act is a controversial issue because on one hand, these drugs could help a dying patient, but on the other hand it could harm them since they have not passed all of the FDAs controls. Although a version of the act has been approved in 38 states, its necessity remains in question by many health organizations.
Why was the Right-to-Try-Act Developed?
RightToTry.org’s website states that over 1 million Americans die from a terminal illness every year. “Many spend years searching for a potential cure, or struggle in vain to get accepted into a clinical trial. Unfortunately, FDA red tape and government regulations restrict access to promising new treatments, and for those who do get access, it’s often too late.”
The original model of the act was written by the Goldwater Institute, a Phoenix-based libertarian think tank. The claim that their goal was to empower patients to make their own health care decisions without government input.
Vice President Pence and President Trump both back the bill. Trump publicly supported the bill at the State of the Union in January by stating: “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.”
What are the Debates Surrounding Right-to-Try?
While the act gives power to the patients, many fear that they, in their vulnerable states, are only going to be robbed by snake oil charmer-like pharmaceutical companies selling them expensive meds without the approval of the FDA.
The opposition also dislikes the fact that it’s circumventing the FDA approval process, questioning the constitutionality and safety of the act. “State right-to-try laws are unconstitutional insofar as they override the FDA’s federally defined role in the drug review and approval process,” said Professor Efthimios Parasidis, an expert on FDA law and policy at the Ohio State University Moritz College of Law and the College of Public Health, in a U.S News & World Report interview.
The American Cancer Society Cancer Action Network, along with over 75 health organizations representing millions of patients, also expressed concern and opposition in a letter addressed to the House of Representatives. They fear that the proposed bill would remove FDA’s role in consultation on proper dosing, route of administration, dosing schedule, and other safety measures under the current program.
What About Cannabis and Right-to-Try?
Although the bill would appear to finally open the door to legal access to cannabis, which still hasn’t passed phase 2 by the FDA, only terminally ill patients would qualify. According to Forbes the patient would need to be in “a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”
What is the FDA’s Position on This?
According to a study by FDA researchers published in the journal Therapeutic Innovation & Regulatory Science in 2016, about 99% of submitted applications for expanded access to almost 9,000 investigational drugs were allowed to proceed over a 10-year period between January 2005 and December 2014.
“Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days,” FDA Commissioner Dr. Scott Gottlieb said in a statement last year that’s published on their website.
Given this information, is there really a dire need for the right-to-try act? It’s still unclear, but I think we have the right to ask more questions about the future of this bill.
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