SACRAMENTO, Calif. (Aug. 24, 2016) – Yesterday, the California Assembly gave final approval to a bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally-ill patients.
A massive bipartisan coalition of 29 Assembly members introduced Assembly Bill 1668 (AB1668) on Jan. 15. The legislation would give terminally-ill patients access to medicines not yet given final approval for use by the FDA.
Last week, the Senate passed a slightly amended version of AB1668 by a 38-0 vote. On Tuesday, the Assembly concurred with the amendments 77-2. The Assembly previously approved the legislation by a 77-2 margin.
The amendment added protections for insurers, limiting their liability for outstanding debt related to the treatment if the patient dies.
AB1668 now heads to Gov. Jerry Brown’s desk. He has 12 days from the date of transmittal to sign or veto the bill. If he doesn’t take action, it will become law without his signature. Last year, 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.
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 would bypass the FDA expanded access program and allow 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.”
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.
More than two-dozen other states have already approved ‘Right to Try’ legislation. However, passage in California would prove 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. And when enough people and enough states say no to federal bans, there’s not much that Washington D.C. can do about it.
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