The House is poised to pass legislation Tuesday that would allow people with terminal illnesses to use drugs that are still being tested by the government.
The legislation has the support of President Trump, who called on Congress to pass the bill during his State of the Union address, and Vice President Mike Pence, who signed an Indiana bill into law when he was governor.
The policy, referred to as “Right to Try,” has been passed in at least 38 states, but the laws are not allowed to circumvent federal law that says drugs must be approved by the Food and Drug Administration before they can be given to patients. Under the bill, patients would be able to request access to medicines as long as they had passed the first phase of scientific review, which determines whether a medication is safe for people but not whether it works. Drug companies would not be required to provide the drugs to patients who request them.
Conservative groups such as the Goldwater Institute and FreedomWorks have urged its passage, saying that patients should have the right to take drugs that might save their lives, but critics say that it gives patients false hope and undermines the government’s oversight process. They also point out that the FDA already allows for patients to have some access through a program known as “compassionate use.” Under that process, the FDA and an expert on an advisory board must approve the request.
Rep. Frank Pallone Jr. of New Jersey, the top Democrat on the House Energy and Commerce Committee, opposes the bill, saying it “provides false hope to patients and their families, who will assume they will have access to investigational therapies even though the bill does nothing to require manufacturers to provide these therapies to the patient.”
The American Cancer Society Cancer Action Network also opposes the bill. The group’s president, Chris Hansen, said he believed the FDA should stay involved when patients try experimental drugs.
“The FDA would not have the opportunity, as they currently do, to provide consultation on dosing, route of administration, dosing schedule and other important safety measures which they are uniquely positioned to understand,” he said.
The Senate passed a version of the bill unanimously last year, but the House version would need to go back to the Senate for another vote. One of the main differences between the two bills is that the House bill defines a patient who would be allowed to access an experimental drug more narrowly. The House version states that the patient must have a medical condition that carries a “reasonable likelihood that death will occur within a matter of months” or would result in “significant irreversible morbidity that is likely to lead to severely premature death.” The Senate version says only that someone must be diagnosed with a life-threatening disease or condition.
House Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Health Subcommittee Chairman Michael Burgess, R-Texas, said the latest version strikes “the right balance for patients and their safety” and that they “look forward to swift action by our Senate colleagues.”
Sen. Ron Johnson, R-Wis., who sponsored the Senate version of Right to Try, said on Twitter that the House should pass the bill.
The Senate led the charge on Right to Try, and @realDonaldTrump and @VP have called on Congress to get it done. It’s time for the House to pass #RightToTry.
— Senator Ron Johnson (@SenRonJohnson) March 12, 2018
Supporters of the legislation say the bill has been a long time coming and have said that they look forward to patients having options when they face a life-threatening illness. Rep. Andy Biggs, R-Ariz., who originally sponsored the House version of Right to Try, said the legislation was an example of an area where Democrats and Republicans had come together, saying it would “give some relief to terminally ill patients who have no further options left to extend their lives.”
