President Trump Signs 'Right to Try' Legislation Allowing Patients Access To Unapproved Drugs
On Wednesday, President Trump signed a bill giving patients with terminal illnesses access to experimental drugs not yet approved by the Food and Drug Administration. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, known as the “right to try” bill, was passed by Congress last week, receiving widespread Republican approval.
Trump has shown support for the legislation in the past, including during his State of the Union address on Jan. 30. “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.”
— Donald J. Trump (@realDonaldTrump) May 30, 2018
The legislation will make unapproved drugs currently undergoing clinical trials available to patients with life-threatening conditions. Patients must have exhausted all other treatment pathways and do not qualify for a clinical trial.
Right to try, which passed 250-169, has divided patients and advocacy groups. Proponents of the bill believe it will allow patients access to potentially life-saving treatments earlier without the time-consuming approach to approving drugs. Other non-FDA-approved drugs include those available in other countries but not the U.S.
“Terminal timelines are measured in months, weeks and days. Not decades,” the Goldwater Institute, a public policy think tank, wrote on its site. “Many potentially life-saving treatments awaiting approval in the U.S. are already available overseas, and have been for years. Sadly, most Americans cannot afford to seek treatment abroad. Many are left without hope.”
A letter signed by 40 patient groups opposing the legislation states the bill will not increase access to experimental drugs by removing the FDA. The FDA already has an expanded access system that allows patients to try experimental drugs currently in clinical trials — 99.7 percent of these requests are approved.
Removing the FDA’s approval could result in more patient harm than good, the coalition wrote. Most denials for experimental drugs come from the drug companies for “reasonable” concerns. These concerns include patient harm, not enough supply for patients not enrolled in the clinical trial or costs.
Opponents also say right to try does not prevent insurance companies from denying coverage of experimental drugs nor does it prevent drug companies from setting prices too high for patients.
“One of the greatest harms caused by this and all right to try legislation is that patients and their advocates believe that these laws give them new rights that may help save their lives,” two opinion contributors wrote for The Hill. “They don’t, nor can they, and the false promise that they hold out is shameful.”
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