A bill that would give some patients access to experimental treatment, with passionate voices arguing for and against it, has cleared its final congressional hurdle and is now awaiting President Donald Trump’s signature.
Big legislation will be signed by me shortly. After many years, RIGHT TO TRY and big changes to DODD FRANK.— Donald J. Trump (@realDonaldTrump) May 23, 2018
Proponents of the “Right to Try” bill say it will allow terminally ill patients and their caregivers to try new, innovative drugs when no alternatives exist, while opponents say it will open the door to patients’ falling victim to unproven, less-vetted medications.
The bill would allow patients diagnosed with a terminal illness to access drugs and devices that have successfully completed the first phase of clinical trials but remain under the next stage and working toward approval by the Food and Drug Administration (FDA).
It would give patients a third option for accessing experimental medicines, whereas they are now limited to enrolling in a clinical trial or taking part in the FDA’s “expanded access” program.
FDA Commissioner Scott Gottlieb testified before Congress last year that the FDA already approves 99 percent of program applications to treat patients with “investigational” drugs. In about 10 percent of those cases, however, it makes “meaningful changes” to enhance patient safety, like tweaking dosing amounts and increasing safety monitoring, which it wouldn’t be able to make for drugs accessed through Right to Try.
Such caveats aside, the FDA would work with Congress to responsibly implement Right to Try legislation, Gottlieb said.
He tweeted a supportive message after the House passed the bill Tuesday.
When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients; and build on #FDA’s longstanding commitment to these important goals #RTT— Scott Gottlieb, M.D. (@SGottliebFDA) May 22, 2018
The Senate approved the Right to Try bill unanimously in February, but debate over the bill was heated in the House of Representatives.
Rep. Frank Pallone of New Jersey, the top Democrat on the House Energy and Commerce Committee, delivered a warning on the House floor speech that it would “provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients.”
Consumer watchdog and patients’ rights groups also campaigned against the bill, with some of them referring to it as the “False Hope Act.”
“The bill passed today will expose vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards,” Dr. Michael Carome, the director of Public Citizen’s Health Research Group, said in a statement Tuesday.
Chris Hansen, the president of the American Cancer Society’s lobbying arm, said in a statement, “The particular legislation passed today risks undermining important patient safety considerations. Excluding experts at FDA from providing input on things like drug dosing, scheduling, and administration is not sound public policy.”
The arguments on the other side were equally passionate.
“Think for a moment how many times you struggle, somebody you know that has some life-ending disease, and if they just had another opportunity for another trial… why wouldn't we want to give people that opportunity?” House Majority Leader Kevin McCarthy, R-Calif., asked during a news conference Tuesday.
The Goldwater Institute, a libertarian think tank that was one of the leading advocates of the federal Right to Try bill, hailed its passage. Forty states already have their own versions.
“Today’s vote is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first,” Victor Riches, the president and CEO of the institute, said in a statement.
White House press secretary Sarah Sanders released a statement Tuesday expressing the president’s support for the bill. He urged Congress to pass such a bill during his State of the Union address in February.
“This administration believes that treatment decisions for those facing life-threatening illnesses are best made by the patients with the support and guidance of their treating physicians,” Sanders said. “This legislation advances these principles.”