TALLAHASSEE, Fla. (June 10, 2015) – A bill that would effectively nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed by Florida Gov. Rick Scott today.

Rep. Ray Pilon (R-Sarasota) along with nine co-sponsors introduced the Florida Right to Try Act in January. House Bill 269 (H269) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.

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.

It passed in the state House unanimously on April 16 with a 113-0 vote, and passed in state Senate last month with a 39-1 vote.

“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 who prescribe these drugs to patients are shielded from liability under H269. The text of the bill states that “a licensing board or disciplinary subcommittee may not revoke, fail to renew, suspend, or take any action against a health care provider’s 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.”

The legislation prohibits action against a health care provider’s Medicare certification based solely on the recommendation that a patient have access to an experimental medical treatment. State officials would be barred from blocking access of these treatments to eligible patients as well. H269 also states that the law would not create a “private cause of action” against a manufacturer or others involved in care as long as they comply in good faith with the terms of the act.

Legislatures in 18 other states have already passed Right to Try Laws similar to this Florida bill, and more 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.

The new law, in effect on July 1 of this year, represents a positive first step to help terminally-ill patients from FDA restrictions that can kill.

ACTION ITEMS

For other states: Take the steps to get a similar bill passed in your state at this link.


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