Dozens of medical organizations and patient advocacy groups are pushing back against so-called “right-to-try” legislation that passed the Senate in August and is now under consideration in the House. An open letter sent today to House leaders is the latest opposition to the Republican-led push to give desperate patients access to experimental drugs without FDA oversight. President Donald Trump urged passage of a right-to-try bill in his State of the Union speech.
“Our organizations support patient access to unapproved therapies,” the letter reads, in part. “However, the right-to-try bills currently under consideration in the House do not effectuate policy changes that would afford our patients greater access to promising investigational therapies. Instead, these bills would likely do more harm than good.”
The 38 signees include the American Lung Association, Susan G. Komen, the Leukemia & Lymphoma Society, the National Organization for Rare Diseases, and the Cystic Fibrosis Foundation.
Existing FDA programs already provide what’s known as compassionate use of experimental drugs for patients outside the clinical trial system. An FDA study published last year said 99 percent of compassionate-use requests from 2005 to 2014 were approved. Commissioner Scott Gottlieb testified before Congress in October in favor of those programs, and he touted recent attempts to improve them to accommodate critics.
New legislation could reduce or eliminate FDA oversight of compassionate use, although the situation is fluid. Stat reported yesterday that a bipartisan compromise bill is in the works that would leave the FDA in charge of compassionate-use programs.
Removing FDA oversight from the process could jeopardize patient safety, say critics of the right-to-try movement. In an op-ed in Stat last week, former biotech executive Michael Becker, who has terminal cancer, raised questions about other risks.
“I’m also worried about the financial, legal, and medical protection afforded to patients and their families under the proposed right-to-try bill,” he wrote. “Do patients undergoing right-to-try therapies lose their coverage for hospice? Would insurers be absolved of any responsibility for covering further medical expenses once a patient starts a drug under right-to-try? What if the experimental drug causes hospitalization or leads to additional treatments—who would pay for that?”
The open letter arrives on the heels of a similar petition signed by more than 300 individuals, including bio-ethicists, researchers, and patient advocates.
The right-to-try movement has persuaded 38 states to pass legislation. Vice President Mike Pence is a major backer; he signed a right-to-try law when he was governor of Indiana.