OLYMPIA, Wash, (May 10, 2017) – Last week, Washington Gov. Jay Inslee signed a bill into law setting the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
A bipartisan coalition of 13 senators sponsored Senate Bill 5035 (SB5035). The new law will enable terminally ill patients to access medications and treatments not yet given final approval for use by the FDA.
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.
SB5035 creates a process to bypass the FDA expanded access program and would 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.
The new law provides legal protection for health care providers by stipulating they do not commit unprofessional conduct under RCW 18.130.180 and do not violate the applicable standard of care based on a recommendation or issuance of investigational treatments. The legislation also includes legal protections for the manufacturers of investigational treatments and healthcare facilities.
SB5035 passed the Senate by a 49-0 vote. The House approved the measure 97-0 on April 6 with some technical amendments. The Senate concurred with the House version 48-0. With Inslee’s signature last Friday, the new law will go into effect later this summer.
Washington became the 34th state to put a Right to Try law on the books. Although these laws only address one small aspect of FDA regulation, they provide a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.
“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 Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.
The new law goes into effect on July 23, 2017.
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