NASHVILLE, Tenn. (May 11, 2015) – A Tennessee bill to nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed into law last week by Gov. Bill Haslam.
Introduced by Rep. John Lundberg (R-Bristol) along with 22 bipartisan co-sponsors, House Bill 143 (HB143) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
The bill passed in the state House on April 2 with a unanimous 94-0 vote, and then passed in the state Senate on April 16 with a unanimous 31-0 vote. After the House re-authorized the bill after slight technical amendments were added by the Senate, the Phil Timp-Amanda Wilcox Right to Try Act was signed into law by Gov. Haslam on May 8.
“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.”
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.
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.
“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.”
HB143 is an important step in the right direction toward health freedom. Tennessee is the seventeenth state to approve this type of reform with 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.
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.