The United States Senate previously approved legislation that would allow the terminally ill to access experimental drugs, commonly known as “Right to Try.” Recently, however, the United States House of Representatives failed to pass the legislation, with a vote of 259 to 140.
House Republicans tried to pass the bill under a suspension of the House rules, which requires any bill to take two-thirds support in order to pass, instead of a simple majority.
President Donald Trump previously showed his support for the bill in his State of the Union address in January 2018. “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.”
The House and Senate bills would establish a new pathway providing access to unapproved prescription drugs for certain patients who had exhausted other treatment options. Under the Senate bill, patients with “a life-threatening disease or condition” could obtain unapproved drugs, but eligibility under the House bill was more narrowly defined.
To qualify under the House bill, a patient would have to have some kind of terminal illness: a condition that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.”
The patient would have to provide informed consent in writing. The manufacturer would have to notify the federal government within seven business days of providing the drug to a doctor for use by a patient, and the doctor must immediately report any “serious adverse events” to the drugmaker.
One of the shortcomings of the Right to Try bill was that patients would have had to foot the bill for the experimental drug themselves, since it was unlikely that payers would cover drugs that were not yet approved by the FDA. Further, there may be additional costs for unforeseen side effects of the medication that may result in hospitalization or other expenses.
There was a bit of partisan back-and-forth chatter about the bill, including the following between Representative Frank Pallone and Representative Morgan Griffith,
“This legislation delivers the false hope to patients and their families that they will receive a cure to their underlying disease or condition,” House Energy and Commerce ranking member Frank Pallone said. The bill is also “based on false premise that patients are not receiving access to investigational treatments as a result of the Food and Drug Administration.”
“There is no false hope. They know it’s a Hail Mary pass,” Rep. Morgan Griffith said. “They know it’s unlikely to succeed, but they are willing to make the decision and choice to take that chance.”
Neither the Pharmaceutical Research and Manufacturers of America (PhRMA) nor the Biotechnology Innovation Organization (BIO) have taken a formal position on the legislation. Instead, the drive for right-to-try legislation was spearheaded by the Goldwater Institute, a public policy organization that advocates free markets and limited government.
Currently, drug companies can provide experimental drugs to patients outside of clinical trials under a program known as expanded access or compassionate use. According to the FDA, the vast majority of compassionate use requests are approved and in emergencies or other urgent cases, the FDA tries to approve requests within hours or days of being contacted by a doctor.
According to House Majority Leader Kevin McCarthy, the House may try again to pass the bill. “We will try again, pass legislation and bring hope to those whose only desire is the right to try to live,” he said. According to a GOP aide, House Republicans are likely to bring a Senate version of the bill to the floor, or try to attach the bill to a larger legislative package.