SACRAMENTO, Calif. (Sept 4, 2015) – On Wednesday, the California gave final approval to a bill that would effectively nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally-ill patients from accessing experimental treatments. The vote was 76-2.
Introduced in January by Asm. Ian Calderon (D-Whittier) and nine bipartisan co-sponsors, Assembly Bill 159 (AB159) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA.
“AB159 is simple: If your parent or your child or even you are faced with a terminal illness, you have the right to try and save your life,” Calderon said.
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 sets the stage to effectively nullify it in practice.
Twenty-four other states have already approved ‘Right to Try’ legislation. However, passage in California is particularly significant, not only because of the impact of the state’s politics on national policy in general, but also 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. 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.
The bill passed originally passed the Assembly with a 74-2 vote in May. It was passed unanimously by the Senate this week. But, the 40-0 vote included a few minor technical amendments, sending it back to the Assembly where it was given final approval yesterday.
“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.”
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.
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 both chambers, it will now go to Gov. Brown’s desk for consideration. Inside sources suggest that he’s likely to sign the bill.
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.