RALEIGH, N.C. (June 16, 2015) – Last week, a North Carolina House Committee passed a bill that would effectively nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments.
Introduced by Rep. Hugh Blackwell (R-Burke), Rep. Mike Hager (R-Rutherford), Rep. Donny Lambeth (R-Forsyth) and Rep. Robert Reives (D-Chatham) along with 22 bipartisan co-sponsors in April, House Bill 652 (H652) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA.
H652 passed unanimously in the state House on April 21 by a 118-0 vote. It was reported favorably out of the Senate Health Care Committee on June 11. The state Senate will now have an opportunity to concur with the state House’s decision to approve the bill.
“This legislation is designed to offer some final hope to patients who have been identified as having a terminal illness and exhausted all their options,” Rep. Blackwell said in a News & Observer report about H652.
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.
“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.”
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. North Carolina has the opportunity to join eighteen states if this ‘Right to Try’ legislation is approved by the state Senate and signed into law. In addition, more than 20 states have introduced similar measures this year.
“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.”
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.