Several hundred “right to try” critics sent a letter to House Energy and Commerce Committee leaders expressing their “strong opposition” to the bill President Trump urged Congress to pass in his State of the Union speech last week.
Supporters of the legislation believed Trump’s endorsement provided a jolt of momentum to the legislation, which would let patients with a serious illness request access to experimental medicines the Food and Drug Administration (FDA) hasn’t approved.
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But the bill has come under criticism from some quarters.
Six academics who work at the intersection of medical ethics and drug development sent the letter, which was circulated for several days online and which gathered more than 330 signatures from other academics, patient advocates, individuals (some of whom identified themselves as cancer survivors) and more.
“This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products,” the letter sent Monday states.
The letter points to the FDA’s compassionate use program — where physicians can ask the FDA to let a terminally ill patient access an unapproved drug — and wrote that the program approves “over 99 percent of the requests for expanded access that it receives.”
“Because the FDA is not the obstacle to patient access to investigational drugs and plays a vital role in ensuring proper patient safeguards are in place, we implore the Committee to not pass legislation that would remove the FDA from the initial authorization process for accessing an investigational therapy outside of a clinical trial.”
Proponents of “right to try” argue that process is onerous.
“Right to try” laws have passed in nearly 40 states, but supporters of the bill say federal legislation is needed so that drug companies could feel more free to grant access to the unapproved drugs to seriously ill patients.
While opponents say the bill could undermine patient safety and drug development, those advocating for the legislation say critically ill patients should have every tool at their disposal to get drugs that could potentially help their disease. However, it’s not clear how many people would benefit, as drug companies aren’t required to give the experimental medications to those who request access.
The bill has powerful backers. For one, Vice President Pence has been a staunch supporter of “right to try” laws, and signed the legislation when he was governor of Indiana.
And groups aligned with conservative mega-donors Charles and David Koch launched a new campaign in early January to push the House to pass the bill. The Senate passed the measure in August by unanimous consent, and some supporters want the Senate’s version to pass the House, so it doesn’t have to ping-pong between the two chambers.
Lawmakers who introduced the legislation met with GOP leadership Monday afternoon.
After the meeting, Sen. Ron Johnson (R-Wis.) said, “We think the Senate bill’s pretty good, but there’s been some issues in the House, and we just need to iron those things out, so we can get it passed.”
In October, the House Energy and Commerce Committee held a hearing on “right to try,” where the agency’s head, Scott Gottlieb, proposed several changes.
When asked if the FDA was working on tweaks, Johnson said, “We’ve been in contact with the FDA commissioner as well.”