NASHVILLE, Tenn. (Apr. 17, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments passed unanimously through the Tennessee state Senate yesterday. It now goes to the Governor’s desk.
Rep. Jon Lundberg (R-Bristol) along with 20 co-sponsors introduced House Bill 143 (HB143) on Jan. 22. The Phil Timp-Amanda Wilcox Right to Try Act pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed. The bill passed through the state House successfully with a 94-0 vote, and then passed through the state Senate successfully with a 31-0 vote.
The legislation will head to the desk of Governor Bill Haslam who has the opportunity to sign the Right to Try Act into law.
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. HB143 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.
“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.”
Health care providers are also protected under the bill, 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. HB143 reads, in part:
A licensing board or disciplinary subcommittee shall not revoke, fail to renew, suspend, or take any action against a healthcare provider’s license… based solely on the healthcare provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. An entity responsible for medicare certification shall not take action against a healthcare provider’s medicare certification based solely on the healthcare provider’s recommendation that a patient have access to an investigational drug, biological product, or device…
This part 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… for any harm done to the eligible patient… if the manufacturer or other person or entity is complying in good faith with the terms of this part and has exercised reasonable care.
HB143 is an important step in the right direction toward health freedom. Legislatures in fourteen other states have already passed Right to Try Laws similar to this Tennessee bill, 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.
Gov. Haslam can be reached at (615) 741-2001.