RALEIGH, N.C. (Sept. 30, 2015) – Patients facing life-threatening illnesses will have more treatment options open to them in North Carolina thanks to new a new law that tears down federal roadblocks that goes into effect Thursday.
The new “Right to Try” law sets the state to nullify in practice some Food and Drug Administration (FDA) rules that stop terminally ill patients from utilizing certain treatments by allowing them to access experimental medications and procedures not yet approved by the federal regulatory agency.
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.
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) gives terminally ill patients access to medicines that have not received final approval for use by the FDA.
H652 passed unanimously in both the North Carolina House and Senate.
“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 new North Carolina law bypasses the FDA expanded access program and allows 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.
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. The law also shields them 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.
The North Carolina law takes an important step in the right direction toward health freedom. The Tar Heel State joins 23 states with Right to Try laws on the books.
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.
The Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.
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