SACRAMENTO (Apr. 10, 2015) – A California bill that would nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments passed unanimously through a state Assembly committee this week. The vote was 17-0.
Introduced by State Assemblyman Ian Calderon (D-Whittier), Assembly Bill 159 (AB159) gives terminally ill patients access to medicines and procedures that have not been given final approval for use by the FDA. It passed through the Assembly Health Committee unanimously with a 17-0 vote on April 7.
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.
“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 bill would also protect health care providers from legal action, specifically any 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. State employees would also be prohibited from trying to stop an eligible patient from using an investigational drug.
AB159 is similar in scope to what California voters passed in 1996, with the Compassionate Use Act. That bill started what some call the modern nullification movement by authorizing the use of marijuana for limited medical purposes in defiance of federal prohibition.
“California started a trend that is bringing down federal prohibition without waiting for Congress to do so,” said Michael Boldin of the Tenth Amendment Center. “By following up on the states that have already passed Right to Try Acts, California can help do the same, help sick people and nullify, in practice, more federal restrictions that hurt people.”
Legislatures in thirteen other states have already passed Right to Try Laws similar to this California bill, and more than 20 states are considering such measures in 2015.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “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.”
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 it has passed through its first committee assignment successfully, AB159 must pass through the Assembly Committee on Business and Professions before it can receive a full vote in the state Assembly.
ACTION ITEMS
For California: Take measures 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.
