States’ Rights: Nullification Spreading As Minnesota Invalidates FDA Restrictions

When Minnesota State Representative Nick Zerwas was 15 years old, he was told he had only months to live. Informed that he wouldn’t be able to get a heart transplant, Zerwas was told by his doctor that he might be saved by a surgical procedure that was still experimental. Said Zerwas: “That was my right to try. I fully believe life is worth fighting for, and government has no role in getting in the way.”

On May 1 Zerwas’ bill, the Minnesota Right to Try Act, passed the state house unanimously, 123-0. It had previously passed the state senate, 60-4, on April 21, and on May 5, Minnesota Governor Mark Dayton signed it into law.

In general the Food and Drug Administration (FDA) prohibits access by patients to experimental drugs, but under its “expanded access” provision, the FDA allows patients with serious or life-threatening diseases access to them, but only with its express prior approval. Minnesota effectively nullified the FDA’s rule and allows Minnesotans direct access to manufacturers with such drugs.

Minnesota is the 16th state to nullify this FDA rule, while more than 20 other states are considering similar measures. In announcing the modest victory of state’s rights over federal overreach, the Tenth Amendment Center said:

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.