The House approved legislation to allow terminally ill the “right to try” experimental drugs not yet approved by the FDA on a largely partisan vote, sending the bill to a supportive President Donald Trump.
Twenty-two Democrats joined Republicans in passing the bill by a vote of 250 to 169. It has the backing of Trump—who mentioned it in his State of the Union address—as well as conservative and libertarian advocacy groups like FreedomWorks.
“Right to Try will allow terminally ill Americans to bypass the bureaucratic red tape and take control of their own health,” the group’s vice president of legislative affairs, Jason Pye, said in a statement to HealthExec. “After all, the right to try is the right to fight for your life.”
Once signed into law, it will permit patients with serious diseases to make requests directly to pharmaceutical companies for treatments still being tested in clinical trials. Dozens of states have passed similar laws in recent years.
The FDA already offers a similar option through its compassionate use program which approves 99 percent of patient requests for access, but advocates of the legislation argued going through the federal government can take too long for patients for little time to spare.
Democrats and patient safety groups, however, have accused “right-to-try” laws of deceiving patients. Without FDA oversight, they argue, treatments could harm patients. Pharma companies also have no obligation to approve a patient’s request and according to those patient advocates, the few times a compassionate use request to the FDA is rejected, it’s because the drug company denying access.
A coalition of 100 advocacy groups was particularly concerned that the House passed an earlier version of the bill approved by the Senate last year. A modified version passed by the House in March included additional protections for patients, they wrote to House leaders on May 21, while the Senate bill would allow “allow unproven therapies to be given to patients without FDA notification for up to a full year and would not establish any standards for informed consent.”
This “substantially worse” legislation, as the groups called it, is now waiting for Trump’s signature.
“It was disappointing that calls from a wide array of patient advocacy groups to preserve critical patient protections provided by FDA were disregarded,” said Chris Hansen, president of the American Cancer Society’s Cancer Action Network. “Enactment of this legislation could do more harm than good to patients in the months and years to come, and we wish Congress would have taken a more deliberative approach to this nuanced issue.”
John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.