SACRAMENTO, Calif. (June 1, 2016) – Yesterday, the California Assembly overwhelmingly passed 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.
On Tuesday, the Assembly passed AB1668 by a 77-2 margin.
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.”
Last year, the California legislature passed a similar bill, but Gov. Jerry Brown vetoed it. Despite the overwhelming support in the legislature,…