HELENA, Mont. (Mar. 31, 2015) – Today, Montana Gov. Steve Bullock signed a bill that nullifies in practice some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally-ill patients.
Introduced by State Sen. Cary Smith, Senate Bill 142 (SB142) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA. It passed the Senate unanimously and the House concurred with a vote of 93-7. With the signature from Gov. Bullock today, Montana is now the 13th state to have passed such a law in the past year.
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. As passed in Montana, SB142 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and effectively nullifies it in practice.
“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.”
Health care providers are also protected under the bills, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are also protected from lawsuits. SB142 reads, in part:
(1) A licensing board may not revoke, fail to renew, suspend, or take any action against a license… based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device.
(2) The department of public health and human services may not take action against a health care provider’s medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device…
A manufacturer of an investigational drug, biological product, or device, a pharmacist, a health care facility, a health care provider, or a person or entity involved in the care of an eligible patient using an investigational drug, biological product, or device is immune from suit for any harm done… if the manufacturer, pharmacist, health care facility, health care provider, or other person or entity is complying in good faith with the terms of this act and has exercised reasonable care.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “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 nullify the FDA like this.”
Legislatures in twelve other states have already passed Right to Try Laws similar to the new Montana law, and more than 20 states are considering such measures in 2015.
Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself. The strategy works because it focuses on ending specific federal policies large numbers of Americans from across the political spectrum oppose.
Take the steps to get a similar bill passed in your state at THIS LINK.