ST PAUL, Minn. (May 7, 2015) – A Minnesota bill to nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed into law this week by Gov. Mark Dayton.
Introduced by Sen. 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. On the House side, the bill was sponsored by Rep. Nick Zerwas (R-Elk River) and 14 co-sponsors.
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.
On the House floor, Zerwas shared a story about his own experience with experimental medical procedures.
As a 15-year-old, Zerwas learned he would not be getting a needed heart transplant and was also told he only had a few months to live. But he said a doctor then suggested an experimental heart surgery.
“That was my right to try,” he said. “I fully believe life is worth fighting for, and government has no role in getting in the way.”
The Minnesota Right to Try Act passed through the state House unanimously on May 1 with a 123-0 vote, and previously passed through the state Senate on April 21 with a 60-4 vote. It was officially signed into law by Gov. Dayton on May 5.
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. Minnesota is the sixteenth state to approve this type of reform while 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.
ACTION ITEMS
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.
