LINCOLN, Neb. (Jan. 11, 2015) – A Nebraska bill introduced last week 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.
Filed by Sen. Bob Hilkemann (R-Omaha), LB804 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.
LB804 would bypass the FDA expanded access program and 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.
“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 law also provides protection to health care providers, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. LB804 reads, in part:
Notwithstanding any provision of law to the contrary, the board of medicine shall not revoke, fail to renew, or take any other action against a physician’s license… based solely on a physician’s recommendation to an eligible patient regarding or prescription for or treatment with an investigational drug, biological product, or device…
Notwithstanding any provision of law to the contrary, the department of health and human services shall not take action against a facility… based solely on the institution’s participation in the treatment or use of an investigational drug, biological product, or device under this chapter.
In addition, lawsuits against physicians who comply under the terms specified in LB804 are prohibited:
The Investigational Drug Use Act does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against another person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from treatment if the manufacturer or other person or entity has complied in good faith with the terms of the act and exercised reasonable care.
Although these type of bills 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.
“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.”
Nebraska looks to join twenty-four other states that have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.
LB804 was referred to the Health and Human Services Committee. The committee must approve the bill before it can receive a full Senate vote.
ACTION ITEMS
For Nebraska: Support this bill by following all the steps at THIS LINK.
For other states: Take action to support Right to Try at this link.
