Right to Try Act: Should Terminally Ill Patients be Able to Try Experimental Treatments? (H.R. 5247)

What is H.R. 5247?

(Updated January 23, 2019)

This bill — known as the Right to Try Act — would allow the use of experimental treatments that haven’t been approved by the Food and Drug Administration (FDA) by terminally ill patients in accordance with state law. Patients must have their physician certify that they’ve exhausted all approved treatment options and are ineligible for clinical trials, and they’d have to provide written informed consent that they’re aware of possible risks.

No producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental treatment could be held liable for providing the patient with the with the treatment. No outcome of the treatment could be used by a federal agency reviewing the treatment to delay or otherwise adversely impact the review or approval of the experimental treatment.

The bill’s full title is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018.

Argument in favor

This bill would give families and individuals access to potentially lifesaving treatments that haven’t been approved by the FDA when they have no alternative. If the patient and physician understand the risks, they should have the right to try experimental treatments.

Argument opposed

This bill is too risky because the FDA and clinical trial process exist to prevent unsafe treatments from being used. Besides, insurers may not pay for it and drug companies may not allow the experimental treatment to be used. It gives patients false hope.

Impact

Terminally ill patients and their physicians; drug companies and insurers; states; and the FDA.

Cost of H.R. 5247

A CBO cost estimate is unavailable.

Additional Info

In-Depth: House Majority Leader Kevin McCarthy (R-CA) brought this bill to the House floor to give terminally ill patients the “right to try” experimental drugs in the hope of prolonging or saving their lives:

“We are a resilient and resourceful nation, and when faced with long odds, Americans should be given the opportunity to harness our country’s vast medical innovation by accessing experimental treatments. As President Trump said in his State of the Union, and as Vice President Pence has long advocated, no one should have to look beyond the UNited States and our world-class health providers for hope. This bill was subject to months of negotiations and I thank Chairman Walden (OR-02), Representatives Brian Fitzpatrick (PA-08) and Andy Biggs (AZ-05), and Senator Ron Johnson (WI) for their commitment to getting it ready for floor action.”

House Minority Whip Steny Hoyer (D-MD) wrote to fellow Democrats expressing opposition to the bill:

“This bill, posted just before midnight on Friday night without committee action, threatens to undermine the drug development process and subject patients to serious risk of harm… This bill would also weaken FDA’s ability to oversee adverse events or other clinical outcomes from the use of an investigational drug and provide broad liability protections for manufacturers and health care providers — leaving patients with no recourse in the case of an adverse event. This unnecessary legislation ultimately seeks to undermine the FDA’s authority to ensure safety and efficacy in the nation’s drug supply while providing false hope to patients.”

Media:

• House Majority Leader Kevin McCarthy (R-CA) Press Release
  
• House Minority Whip Steny Hoyer (D-MD) Whip Notice (Opposed)
  
• Washington Post