TRENTON, N.J. (Feb. 22, 2018) – Two bills introduced in the New Jersey state legislature 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.
Sen. Joseph Vitale (D-Middlesex) introduced Senate Bill 955 (S955) and Rep. Pamela Lampitt (D-Cherry Hill) introduced Assembly Bill 1830 (A1830) with three bipartisan co-sponsors. Both bills are continuations from initiatives that were pursued during the previous legislative session. The bills would give terminally ill patients access to medicines 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.
S955 and A1830 would create a process to bypass the FDA expanded access program and allows 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 proposed laws would prevent health care providers from being sanctioned by the State Board of Medical Examiners for recommending any experimental medications or procedures to terminal patients. The legislation would also ban state-level officials from interfering in this process in any way.
Thirty-eight states now have Right to Try laws 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.
A1830 must pass the Assembly Health and Senior Services Committee while S955 must pass the Senate Health, Human Services and Senior Citizens Committee before either bill can be considered in their respective chambers for a full vote.