CARSON CITY, Nev. (May 28, 2015) – Yesterday, Nevada Gov. Brian Sandoval signed a bill into law that effectively nullifies in practice some Food and Drug Administration (FDA) rules preventing terminally ill patients from accessing experimental treatments.
Introduced by Assemblyman James Ohrenschall (D-Las Vegas) and 15 bipartisan co-sponsors, Assembly Bill 164 (AB164) allows terminally ill patients access to medicines that have not been given final approval for use by the FDA.
AB164 had previously passed in the Assembly by a 41-0 vote, and the Senate by a 20-0 vote. It was signed into law by Gov. Sandoval on May 27.
“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 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. AB164 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.
Health care providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. AB164 reads, in part:
An osteopathic physician is not subject to disciplinary action for prescribing or recommending an investigational drug, biological product or device.
In addition, state officials are now barred from unlawfully interfering in the process of patients receiving experimental drugs and procedures. AB164 reads, in part:
An officer, employee or agent of this State shall not prevent or attempt to prevent a patient from accessing an investigational drug, biological product or device that is authorized to be provided or made available to a patient pursuant to this section.
“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.”
AB164 is an important step in the right direction toward health freedom. Nevada has become the eighteenth state to sign ‘Right to Try’ legislation into law. In addition, more than 20 states are considering such measures in 2015.
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.
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.