JUNEAU, Alaska (Feb. 19, 2018) – A bill moving through the Alaska Senate 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.
Rep. Jason Grenn (I-Anchorage) introduce House Bill 43 (HB43) last year and it carried over into the 2018 legislative session. The bill 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.
HB43 creates 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.
On Jan. 31, the Senate Health and Social Services Committee approved HB43 by a 4-1 vote. The House passed HB43 by a 40-0 vote last spring.
The proposed law includes legal protections for healthcare providers, shielding them from legal liability “in an action for damages for the injury or death of a patient with a terminal illness resulting from the patient’s use of an investigational drug, biological product, or device for the purpose of sustaining the patient’s life if the person, acting in good faith and with reasonable care.” The legislation provides similar protections for manufacturers of an experimental treatment.
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.
HB43 now moves to the Senate Judiciary Committee where it must pass by a majority vote before moving to the Senate floor for a vote. A hearing in Judiciary is scheduled for Feb, 26.