ST. PAUL, Minn. (Apr. 23, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments passed through the Minnesota state Senate this week. The vote was 60-4.
Introduced by State Senator Branden Petersen (R-Andover) along with four bipartisan co-sponsors, Senate File 100 (SF100) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed. The Minnesota Right to Try Act passed through the state Senate on April 21 with a 60-4 vote.
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. SF100 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.
“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.”
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. They are also protected from lawsuits. SF100 reads, in part:
No health care provider shall be subject to a civil penalty or disciplinary action by any business, occupational, or professional licensing board, solely for providing a prescription or recommendation, or providing treatment to an eligible patient in accordance with this section…
Nothing in this section shall create a separate private cause of action against any health care provider or entity involved in the care of an eligible patient… for any harm done to the patient resulting from the investigational drug, biological product, or device, so long as the health care provider or entity is complying with the requirements of this [Act].
SF100 is an important step in the right direction toward health freedom. Legislatures in fifteen other states have already passed Right to Try Laws similar to this Minnesota bill, and 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.
Now that it passed through the state Senate successfully, SF100 must be approved by the state House before it can be placed on the Governor’s desk.
For Minnesota: Take steps to support SF100 at THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at this link.