RALEIGH, N.C. (Apr. 22, 2015) – A bill that would nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments passed unanimously through the North Carolina state House yesterday.

Introduced by State Reps. Hugh Blackwell (R-Burke), Mike Hager (R-Rutherford), Donny Lambeth (R-Forsyth) and Robert T. Reives (D-Chatman) along with 22 bipartisan co-sponsors, House Bill 652 (H652) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed. The North Carolina Right to Try Act passed through the state House unanimously on April 21 with a 118-0 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. H652 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. H652 reads, in part:

A licensing board shall not revoke, fail to renew, suspend, or take any other disciplinary action against a health care provider… based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device.

An entity responsible for Medicare certification shall not take action against a health care provider’s Medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device…

No private right of action may be brought against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient using an investigational drug, biological product, or device, for any harm caused to the eligible patient… as long as the manufacturer or other person or entity has made a good‑faith effort to comply with the provisions of this Article.

H652 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 North Carolina 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 House successfully, H652 must be approved by the state Senate before it can be placed on the Governor’s desk.

ACTION ITEMS
For North Carolina: Take steps to support H652 at THIS LINK.

For other states: Take the steps to get a similar bill passed in your state at this link.