SACRAMENTO, Ca. (May 24, 2015) – On Tuesday, the California state Assembly 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 74-2.
Introduced in January by Asm. Ian Calderon (D-Whittier) and nine bipartisan co-sponsors, Assembly Bill 164 (AB159) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA. It passed in the state Assembly on May 18 by a 74-2 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. AB159 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.”
Similar bills have been signed into law in 17 other states since last year, and bills in Illinois, Florida and Nevada are awaiting action at the Governor’s desk. But passage in California is 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.”
ADDITIONAL PROTECTIONS
The bill prohibits state officials from any actions that would prevent the lawful administering of experimental procedures to eligible patients. AB159 reads, in part:
An official, employee, or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device… Counseling, advice, or a recommendation consistent with medical standards of care from an individual licensed… shall not be considered a violation of this section.
This is important, since in the early days of legal medical marijuana – and still to some extent today – local law enforcement worked closely with federal agencies to take aggressive actions to stop the program.
“Including this provision ensures that the ‘boots on the ground’ for law enforcement – the locals, won’t be taking any action to stop sick people from trying new treatments. The feds will have to handle it, and they don’t have the manpower or resources to get the job done,” said Boldin.
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. AB159 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…
[AB159] does not create a private cause of action against a manufacturer… 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 done to the eligible patient… unless there was a failure to exercise reasonable care.
NEXT UP
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 AB159 has passed successfully through the state Assembly, the bill now moves to the state Senate for further consideration. It will first need to pass through committee assignments before the Senate can concur and send the bill to 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.
