TALLAHASSEE, Fla. (Apr. 16, 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 Florida state House today.
Introduced by Rep. Ray Pilon (R-Sarasota) and nine co-sponsors, House Bill 269 (H269) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA. It passed the state House unanimously with a 113-0 vote on April 16.
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. H269 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 bills, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB269 reads, in part:
A licensing board may not revoke, fail to renew, suspend, or take any action against a physician’s license… based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. A state entity responsible for Medicare certification may not take action against a physician’s Medicare certification based solely on the physician’s recommendation that an eligible patient have access to an investigational drug, biological product, or device.
There shall be no liability on the part of, and no cause of action of any nature shall arise against, any person, including a physician, pharmacist, manufacturer, or distributor, who possesses, stores, or administers an investigational drug, biological product, or device in compliance with this section. Such immunity does not apply to any willful tort.
H269 is an important step in the right direction toward health freedom. Legislatures in thirteen other states have already passed Right to Try Laws similar to this Florida 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.
Now that H269 has passed through the state House successfully, the state Senate must concur with their decision before the bill can be put onto the Governor’s desk.
For Florida: Take measures to support this bill AT THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at this link.