SACRAMENTO, Ca. (June 5, 2015) – On Tuesday, the California state Senate unanimously passed a bill that would effectively nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments. The vote was 39-0.
Introduced in January by Sen. Jeff Stone (R-Palm Desert) and Sen. Joel Anderson (R-Alpine), Senate Bill 149 (SB149) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA. It passed in the state Senate on June 2nd with a unanimous 39-0 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. SB149 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. SB149 reads, in part:
A state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based solely on the physician’s recommendation to an eligible patient regarding, or prescription for, or treatment with, an investigational drug, biological product, or device pursuant to this article…
A state agency shall not take any action against a health facility’s license based solely on the facility’s participation in the treatment by or use of an investigational drug, biological product, or device pursuant to this article…
This article 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 using the investigational drug, biological product, or device, for any harm to the eligible patient… so long as the manufacturer or other person or entity complies in good faith with the terms of this article and exercises reasonable care.
Eighteen other states have approved ‘Right to Try’ legislation, and a similar bill (AB159) passed by an overwhelming margin in the California state Assembly earlier this year. But passage in California is particularly significant, not only because of the impact of the state’s politics on national policy in general, but because it follows a path that voters there started nearly twenty years ago.
“Back in 1996, California voters recognized that keeping medicine away from sick people was a federal policy they could no longer ignore, and they passed Prop 215 to legalize medical marijuana” said Tenth Amendment Center Executive Director Michael Boldin. “The Right to Try Act is based on the same principle. And when enough people and enough states say no to federal bans, there’s not much that Washington D.C. can do about it.”
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 SB149 passed in the state Senate, the state House must concur with their decision before the bill can be put on the Governor’s desk.
ACTION ITEMS
For California: Take steps 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.
