Round Two: Right-To-Try Legislation Passes in House

Last Wednesday, the House of Representatives passed a bill that aims to give terminally ill patients the “right-to-try” drug treatments that have not yet been approved by the Food and Drug Administration (FDA). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, introduced as H.R. 5247, received a majority vote of 267 to 149. The previous week, the bill failed to receive the required two-thirds majority vote in the House to proceed. As reintroduced, the bill required only a simple majority vote to pass.

During debate on the House floor Wednesday, Representative Frank Pallone Jr. (D-N.J.), the top Democrat on the House Energy and Commerce Committee, asserted that allowing patients to access investigational treatments that have only completed a phase 1 clinical trial would expose patients to treatments with little or no efficacy data. The American Cancer Society Cancer Action Network (ACS CAN), along with over 75 organizations representing millions of patients, expressed concern and opposition to the bill, saying not only would it remove FDA approval and consultation, but it would also fail to increase access to promising therapies since the bill does not address primary barriers to access to investigational therapies. ACS CAN further stressed opposition since the proposed bill would remove FDA’s role in consultation on dosing, route of administration, dosing schedule, and other safety measures under the current program.

Proponents of the legislation, such as House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), note that 38 states have right-to-try legislation and point to additional monetary federal support. Supporters maintain that the bill strikes the right balance for patients and their safety, arguing that those with a terminal illness should have every tool at their disposal. However, critics of the legislation fear it could lead to a slippery slope of bypassing FDA regulations. Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania, said the bill probably would not increase access to investigational drugs beyond what the FDA already allows. According to Professor Lynch, “[t]he bigger challenge is this attack on the FDA’s very reason for existence.”

The bill will now move back to the Senate for approval. Last August, the Senate approved similar legislation. If approved, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 would introduce legislation across state lines. Whether the federal bill will increase access to unapproved treatments for terminal patients remains an open question.

 

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