MONTGOMERY, Al. (May 4, 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 Alabama state Senate last week. The vote was 29-0.

Introduced by State Senator Cam Ward (R-Alabaster) in April along with five co-sponsors, Senate Bill 357 (SB357) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed. The Alabama Right to Try Act passed unanimously through the state Senate on April 30 with a 29-0 vote.

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. SB357 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. SB357 reads, in part:

A licensing board or disciplinary subcommittee shall not issue a letter of concern or similar form of reprimand, nor 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. An entity responsible for Medicare certification shall not reprimand or 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…

This act does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any licensed health care provider, other person, or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this act, unless there was a failure to exercise reasonable care.

In addition, state officials are barred from unlawfully interfering in the process of patients receiving experimental drugs and procedures under SB357. The bill mandates that state officials “shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”

SB357 is an important step in the right direction toward health freedom. Legislatures in fifteen other states have already passed Right to Try Laws similar to this Alabama 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 it passed through the state Senate successfully, SB357 must be approved by the state House before it can be placed on the Governor’s desk.

ACTION ITEMS
For Alabama: Take steps to support SB357 at THIS LINK.

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

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