SACRAMENTO, Calif. (Jan 2, 2017) – Yesterday, a California law went into effect that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules denying access to experimental treatments by terminally-ill patients.
A massive bipartisan coalition of 29 Assembly members introduced Assembly Bill 1668 (AB1668). The legislation gives terminally-ill patients access to medicines not yet given final approval for use by the FDA.
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.
AB1668 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.
“Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Darcy Olsen, president of the Goldwater Institute. “They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”
“I would like to thank Governor Brown for his efforts and support in giving terminally ill patients a right to hope – and a right to try and save their own lives,” stated Majority Leader Calderon. “Terminally ill patients in our state will finally have access to potentially life-saving treatments. I am grateful to the Governor for making this a reality.”
FACILITATING THE NEW PROGRAM
The legislation features several provisions that would facilitate the state program. It would authorize, but not require, a health benefit plan to provide coverage for any investigational treatment pursuant to the law. It would also prohibit the Medical Board of California and the Osteopathic Medical Board of California from taking any disciplinary action against the license of a physician based solely on a recommendation to an eligible patient regarding treatment with an investigational drug.
Finally, the bill would prohibit a state agency from altering any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an experimental treatment or drug.
An amendment during the process added protections for insurers, limiting their liability for outstanding debt related to the treatment if the patient dies.
Last session, the California legislature passed a similar bill, but Brown vetoed it. Despite the overwhelming support in the legislature, there was no attempt to override the veto.
Thirty-three other states have already approved ‘Right to Try’ legislation.
“Millions of Americans are dying this year from terminal illnesses for which there are treatments and cures. About 40,000 women with breast cancer will hear from their doctor this year that there are no treatment options left. But there are 22 pioneering breast cancer treatments waiting for the FDA’s green light; some of them are already available and saving lives in Europe,” said Darcy Olsen, president and CEO of the Goldwater Institute.
Passage in California proves 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 20 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.
“When enough people and enough states say no to federal bans, there’s not much that Washington D.C. can do about it,” said Michael Boldin of the Tenth Amendment Center.
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