SACRAMENTO, Calif. (Oct. 13, 2015) – On Sunday, California Governor Jerry Brown vetoed a bill that would have effectively nullified in practice some Food and Drug Administration (FDA) rules that prevent terminally-ill patients from accessing experimental treatments.
Introduced by Asm. Ian Calderon (D-Whittier) and nine bipartisan co-sponsors, Assembly Bill 159 (AB159) would have given terminally ill patients access to medicines that have not been given final approval for use by the FDA.
Brown deferred to federal authority in vetoing the bill, the same position he took when he refused to sign legislation last week that would have taken steps toward ending militarization of California police departments.
“Patients with life threatening conditions should be able to try experimental drugs, and the United States Food and Drug Administration’s compassionate use program allows this to happen,” Brown wrote in his veto message. “Before authorizing an alternative state pathway, we should give this federal expedited process a chance to work.”
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. Earlier this year, the FDA announced it was streamlining the process.
But AB159 would have bypassed the FDA expanded access program altogether, allowing patients to avoid federal red tape and obtain experimental drugs from manufacturers without FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to effectively nullify it in practice.
“This is a baffling veto,” Tenth Amendment Center national communications director Mike Maharrey said. “Why in the world would you wait to see if the FDA program works? Of course it won’t work. Gov. Brown is basically putting people’s lives in the hands of the equivalent of the DMV.”
Kurt Altman, the national policy adviser for the Arizona-based Goldwater Institute released a statement Sunday, saying Brown “has deprived Californians of the right to try to save their lives when their mortality hangs in the balance. We hope that the Legislature will work together in a bipartisan effort to override Governor Brown’s veto.”
Mike DeBartoli puts a human face on exactly what this veto means. The former Sacramento firefighter suffers from ALS. He released a statement, reported by the San Jose Mercury News.
“I am very disappointed,” he wrote. “This allows the FDA to retain control over my ability to save my own life while I still have time. Terminal patients in California now have no possibility of hope to prolong their lives.”
Twenty-four other states have already approved ‘Right to Try’ legislation. However, passage in California was 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. The Senate unanimously approved the measure 40-0, meaning the potential for a veto override exists.
“The Right to Try Act is a no-brainer,” Maharrey said. “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.”
ACTION ITEM: Take the steps to get a similar bill passed in your state at THIS LINK.
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