AUGUSTA, Maine (April 1, 2016) –  On Wednesday, Maine Gov. Paul LePage signed a bill into law that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.

Rep. Thomas Longstaff (D-Waterville) introduced House Bill 180 (LD180) last year, and the bill was carried over to the 2016 session. The legislation would enable terminally ill patients to access to medications and treatments not yet given final approval for use by the FDA.

The House gave final approval to the legislation 114-28. The Senate concurred the following day by a 20-11 margin. With LePage’s signature, LD180 will go into effect 90 days after the end of the current legislative session.

The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval.

LD180 creates a process to bypass the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.

Physicians who prescribe these drugs and procedures to patients, along with manufacturers are shielded from liability under the new law. The bill states “this chapter does not create a private cause of action against a manufacturer of an investigational drug, biological product or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product or device for any harm done to the eligible patient resulting from the investigational drug, biological product or device if the manufacturer or other person or entity is complying in good faith with the provisions of this chapter and has exercised reasonable care.”

LD180 further stipulates that a licensing board may not revoke, refuse to renew or suspend the license of or take any action against health care practitioners based on their recommendation of an experimental treatment.

“Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Darcy Olsen, president of the Goldwater Institute. “They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”

Maine becomes the 26th state to passed similar legislation into law. Although Right to Try bills only address one small aspect of FDA regulation, they provide a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.

The Right to Try Act is a no-brainer. When someone is on their deathbed, the fact that FDA regulations would let them die rather than try, has got to be one of the most inhumane policies of the federal government. Every state should take action to nullify the FDA like this.

Mike Maharrey

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