House introduces 'Right to Try' legislation to permit use of unproven drugs for dying patients

The House Energy and Commerce Committee has released a new version of "Right to Try" legislation that would help dying patients access unproven, investigational drugs.

The House Energy and Commerce Committee has released a new version of "Right to Try" legislation that would help dying patients access unproven, investigational drugs. Under the legislation, "eligible patients" are defined as those with "a stage of disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death." According to committee chairman Rep. Greg Walden (R-OR) and health subcommittee chairman Michael Burgess (R-TX), this is "a complicated issue with passionate advocates on both sides and it was imperative we got the policy right. After months of thoughtful discussions, we believe this legislation is ready for a vote in the House." The legislation would require patients to have tried all other approved treatment options and use a drug that has already passed the earliest stage of a clinical trial, and physicians for such patients would have to report "serious adverse events" from the drug to the manufacturer. Additionally, FDA would not be allowed to use any negative clinical outcomes from the drug to "delay or adversely affect" review and approval of the medicine.