CONCORD, N.H. (June 16, 2016) – Last week, New Hampshire Gov. Maggie Hassan signed a bill setting the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Rep. Frank Edelbut (R-Wilbut) sponsored House Bill 1138 (HB1138). The new law provides terminally ill patients access to medicines not yet given final approval for use by the FDA.
HB1138 passed the Senate on a voice vote last month. In March, the House also passed the measure on a voice vote. The Senate amended the bill so that it would go into immediate effect and the House concurred. With Gov. Hassan’s signature, Right to Try became law in New Hampshire.
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. HB1138 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 new 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. HB1138 reads, in part:
Notwithstanding any provision of law to the contrary, the board of medicine shall not revoke, fail to renew, or take any other action against a physician’s license issued pursuant to RSA 329 based solely on a physician’s recommendation to an eligible patient regarding or prescription for or treatment with an investigational drug, biological product, or device…
II. Notwithstanding any provision of law to the contrary, the department of health and human services shall not take action against a facility licensed under RSA 151 based solely on the institution’s participation in the treatment or use of an investigational drug, biological product, or device under this chapter.
It provides similar legal protections to manufacturers of experimental medications and treatments.
“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.”
So far, more than two-dozen other states have passed similar legislation into law. Although Right to Try bills only address one small aspect of FDA regulation, they provide 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.
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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