COLUMBIA, S.C. (June 5, 2016) – On Friday, South Carolina Gov. Nikki Haley signed into law a bill that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally-ill patients.
A bipartisan coalition of seven Representatives sponsored House Bill 4542 (H.4542). The new law gives terminally ill patients a path to some treatments that have not been given final approval for use by the FDA.
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.
H.4542 would bypass the FDA expanded access program and allow 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 House passed the measure 71-25 back in March. Meanwhile, the Senate unanimously passed a similar bill (S.929) in February. On May 31, the Senate took up the House bill and passed an amended version 42-0. The House concurred with the amendments 78-17 the following day.
Haley signed the bill on Friday.
H.4542 prohibits any state agency from interfering with access to experimental treatments.
“No official, employee, or agent of this State shall block or attempt to block an eligible patient’s lawful access to an investigational drug, biological product, or device.”
It 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. H.4542 reads, in part:
A licensing board shall not revoke, fail to renew, suspend, or take any other disciplinary action against a health care provider licensed in this State, 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 resulting from the use of the investigational drug, biological product, or device as long as the manufacturer or other person or entity has made a good-faith effort to comply with the provisions of this chapter and has exercised reasonable care in actions undertaken pursuant to this chapter.
Although Right to Try laws only addresses one small aspect of FDA regulation, it provides a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.
More than two-dozen states currently have Right to Try in place. The rapid progress of this legislation shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.