ALBANY, N.Y. (Jan. 18, 2016) – A bill introduced in the New York Senate sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.

Introduced by Sen. Kemp Hannon (R-Nassau County), Senate Bill 2044 (S2044) would give terminally ill patients access to medicines not yet 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.

S2044 creates a process to bypass 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. S2044 reads, in part:

Neither the education department nor the state board for professional medical conduct shall revoke, fail to renew, suspend or take any action against a health care provider’s license, 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, so long as the recommendations are consistent with medical standards of care.

In addition, lawsuits against physicians who comply under the terms specified in S2044 are prohibited:

This article shall not be deemed to create a private cause of action 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 the investigational drug, biological product or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device so long as the manufacturer or other person or entity is complying in good faith with the terms of this article; unless there was a failure to exercise reasonable care.

To date, 33 states have right to try laws on the books. Although these laws 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.

“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 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.

NEXT UP

S2044 was referred to the Senate Health Committee. The committee must approve the bill before it can receive a full Senate vote.