House lawmakers on Saturday introduced “right to try” legislation that would allow terminally ill patients to experiment with drugs that haven’t been approved by the FDA.
"Right to try" is a priority for President Trump, who in January urged Congress to pass legislation on it during his State of the Union address.
“We…believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives,” said Trump. “People who are terminally ill should not have to go from country to country to seek a cure - I want to give them a chance right here at home.”
Members of the House Energy and Commerce Committee have been making changes to the Senate version of the bill, which passed unanimously in August.
One of the key supporters of the House bill is the Goldwater Institute, a Koch-backed libertarian public policy think tank that has helped establish "right to try laws" in 38 states. The Right to Try Act will “provide millions of terminally ill Americans an additional pathway to access promising investigational treatments before it’s too late," said the organization.
"Right to try” is critically important for two reasons:
- Primarily, it allows people who are dying to try experimental treatment (which they should have a right to do anyway)
- Second, it will reduce the number of sick people who travel overseas looking for experimental treatments
What makes “right to try” legislation controversial is how you decide which patients are sick enough to qualify. If the definition is too broad, you risk exposing a large number of patients to potentially dangerous drugs. If the definition is too narrow, you aren’t really making a difference.
The House bill proposes “right to try” for patients who are likely to die “within a matter of months” or have a disease or condition that “would result in significant irreversible morbidity that is likely to lead to severely premature death.” To be eligible, patients must also have exhausted all other approved treatments.
Those who qualify will have access to drugs that have passed Stage 1 of clinical trials. The bill also requires doctors to report adverse effects and allows drugmakers to decline requests for unapproved drugs.
“Following its passage, I look forward to swift Senate action so more Americans facing dire circumstances can find some light in their darkest moments,” said House Majority Leader Kevin McCarthy (R-CA).
The House is expected to pass the bill Tuesday.
Critics insist “right to try” laws give manufacturers the opportunity to exploit patients.
“It is important to remember that the current regulatory system for medical products and research in the United States was created as a result of serious patient harm and exploitation that occurred early in the 20th century,” reads a February letter signed by 38 patient advocacy groups. “Clinical research subject protections are in place when experimental products are being tested to ensure the safe and ethical treatment of research participants.”
Others insist "right to try" is a conservative plot to undermine the FDA.
The FDA already has a system in place that it says provides more than 99% of patients with access to unproven medications. Lawmakers say the FDA program takes too long.
The FDA's expanded access program includes “important ethical and safety mechanisms” to protect patients, says American Cancer Society spokesperson Alissa Crispino. The House bill “removes important safety protections and creates openings for potential bad actors to take advantage of patients.”
The FDA says it has been working with lawmakers in order to “provide technical assistance” and “ensure patients are also protected."