Dying patients would get the chance to try experimental drugs in the early stages of development under a bill that passed the House of Representatives late Wednesday.
The so-called right-to-try legislation, sponsored by Rep. Brian Fitzpatrick (R-Pa.), got a boost from President Donald Trump during his State of the Union address in January.
The 267-149 vote came a week after Democrats blocked an attempt to put the bill on a fast track through a procedure that needed a two-thirds majority. The bill drew support from 35 Democrats, while just two Republicans voted “no.”
The bill, which still faces uncertain prospects in the Senate, would give terminally ill patients the right to seek experimental drugs that have completed the first phase of what can be years of trials that the Food and Drug Administration (FDA) requires before approval. It also would give protection from lawsuits to participating doctors, hospitals, drugmakers, and clinical investigators.
Supporters contend that patients who have no other viable options should have the right to assume extra risk in trying drugs that will not be commercially available until years after they die. Rep. Phil Roe (R-Tenn.) spoke during the debate about his wife, Pam, who died of colon cancer three years ago.
“She would have liked to have the right to try,” he said.
Many Democrats, however, argued that the bill is unnecessary and could have unintended consequences. Rep. Jan Schakowsky (D-Ill.) noted that four former FDA commissioners — Republican and Democrat — oppose the legislation.
She said it creates opportunities “for people who may or may not be preying on desperate people and ignores that there actually is a safe pathway for those who are terminally ill to get treatment. This bill failed to pass last week, and it should fail again.”
Schakowsky said the FDA already has a program called Expanded Access, which allows terminally ill patients to bypass red tape and try medicines that have not been approved. She said the agency approves 99 percent of the requests it receives under the program.
“This bill denies patients what they really need — safe and effective treatments,” she said. “This bill strips away important safeguards in the name of helping patients.”
Rep. Doris Matsui (D-Calif.) said “right-to-try” legislation would create unacceptable risk.
“Rescinding any FDA oversight on unproven therapies that [have] not undergone multiple clinical trials is a slippery slope,” she said.
Rep. Greg Walden (R-Ore.), chairman of the House Energy and Commerce Committee, said the GOP tried to pass the bill last week, “never imagining that Democrats would whip against giving dying patients the right to try one of these drugs.”
Walden noted that 38 states already have right-to-try laws, with Wisconsin set to soon become the 39th. He praised the Expanded Access program.
“But it doesn’t do it all,” he said. “And that’s why this legislation is before us.”
Walden said the liability protections in the bill, which also would benefit Expanded Access participants, would address one of the biggest deterrents identified by the Government Accountability Office — a hesitancy of manufacturers to make unapproved drugs available.
“That’s the hurdle we’re trying to overcome today in a safe way,” he said.
Rep. Frank Pallone (D-N.J.) said the bill offers “false hope” to dying patients by exposing them to treatments that show little evidence that they are effective.
Rep. Andy Harris (R-Md.), a physician, rejected the argument.
“That’s a fallacious and specious argument to make when you’re talking about denying people who have a terminal illness, who have been diagnosed with a terminal illness, who have gone through all the already-approved FDA processes in order to get and petition a pharmaceutical company with an experimental drug that might prolong their life and might heal them,” he said.
Brent Gardner, chief government affairs officer with Americans for Prosperity, said in a statement that Wednesday’s vote offered “another chance for members of Congress to advance this compassionate policy that gives hope and could save lives.”