SACRAMENTO, Calif. (June 12, 2015) – On Wednesday, a California Senate Committee unanimously passed a bill that would effectively nullify in practice someย Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments. The vote was 8-0.
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.
The bill passed in the Senate Health Committee on June 10 with a unanimous 8-0 vote. It had previously passed in the state Assembly on May 18 with a 74-2 vote. Similar legislation (SB149) passed in the state Senate unanimously on June 2 with a 39-0 vote. These developments indicate that California may be next in a long line of states that have taken measures to open up experimental drugs and procedures to the gravely sick.
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.
โThe Right to Try Act is a no-brainer,โ said Mike Maharrey of the Tenth Amendment Center. โWhen 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.โ
Eighteen other states have already approved โRight to Tryโ legislation. However, passage in California is particularly significant, not only because of the impact of the stateโs politics on national policy in general, but also because it follows a path that voters there started nearly twenty years ago.
โBack 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 marijuanaโ said Tenth Amendment Center Executive Director Michael Boldin. โThe Right to Try Act is based on the same principle. And when enough people and enough states say no to federal bans, thereโs not much that Washington D.C. can do about it.โ
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 patientโs access to an investigational drug, biological product, or deviceโฆ Counseling, advice, or a recommendation consistent with medical standards of care from an individual licensedโฆ shall not be considered a violation of this section.
This is important, since in the early days of legal medical marijuana โ and still to some extent today โ local law enforcement worked closely with federal agencies to take aggressive actions to stop the program.
โIncluding this provision ensures that the โboots on the groundโ for law enforcement โ the locals, wonโt be taking any action to stop sick people from trying new treatments. The feds will have to handle it, and they donโt have the manpower or resources to get the job done,โ 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 physicianโs license based solely on the physicianโs recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or deviceโฆ
[AB159] does not create a private cause of action against a manufacturerโฆ 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 patientโฆ 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 passed in the Senate Health Committee, the bill moves to the Senate Business, Professions and Economic Development Committee. If it passes its new committee assignment, AB159 will receive a full vote in the state Senate.
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.
