SIGNED AS LAW: NORTH CAROLINA EXPANDS RIGHT TO TRY ACT, REJECTS SOME FDA RESTRICTIONS
RALEIGH, N.C. (July 8, 2019) – Last week, North Carolina Gov. Roy Cooper signed a bill expanding the state’s Right to Try law. The expanded provisions allow certain patients to access stem cell treatments not yet given final approval by the FDA, nullifying some agency regulations in effect.
A bipartisan coalition of four sponsors and 10 cosponsors introduced House Bill 934 (H934) on April 16. The legislation authorizes the use of certain investigational adult stem cell treatments for patients with certain terminal or chronic illnesses under the state’s Right to Try law. H934 includes language to protect physicians who recommend investigational stem cell treatments.
A licensing board shall not revoke, fail to renew, suspend, or take any other disciplinary action against a physician licensed under this Chapter, based solely on the physician’s recommendation that an eligible patient have access to an investigational adult stem cell treatment, or the physician’s administration of an investigational adult stem cell treatment to the eligible patient, provided that the recommendation made or the care provided is consistent with the applicable standard of care and the requirements of this Part.
The law also prohibits any state or local government agency or employee from interfering with an eligible patient’s access to an experimental stem cell treatment.
The House passed H934 by a 114-0 vote. The Senate approved it with some technical amendments 42-0 and the House unanimously concurred with the amendments. With Gov. Cooper’s signature on July1, the law will go into effect on Dec. 1.
BUILDING AGAINST FDA RESTRICTIONS
H934 builds on and expands the North Carolina Right to Try law that went into effect in 2015. The law authorizes terminally ill patients to access experimental treatments not yet approved by the FDA.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs and treatments. 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. RIght to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA approval.
Congress passed a federal Right to Try law last year after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
H934 goes a step further, specifically authorizing experimental stem cell treatments in North Carolina without regard to FDA regulations and expanding access beyond terminally ill patients to include those with chronic illnesses.
This expansion of Right to Try demonstrates an important strategic point. Passing bills that take a step forward sets the stage, even if they are limited in scope. Opening the door clears the way for additional steps. You can’t take the second step before you take the first.
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A West Virginia bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients passed out of the state Senate yesterday.
