ANNAPOLIS, Md. (Oct 2, 2017) – Yesterday, a Maryland law went into effect 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.
Del. Karen Young (D-Frederick) sponsored House Bill 584 (HB584) along with 18 bipartisan co-sponsors. The new law allows terminally ill patients access to medicines and treatments 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.
HB584 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.
In March, the House unanimously passed HB584 by a 139-0 vote. On April 7, the Senate approved the measure 46-0. With Gov. Hogan’s signature, HB584 went into effect Oct 1.
The impact of Right to Try isn’t merely theoretical.
Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law. (Watch a video about Dr. Delpassand here.)
The new law includes protections for healthcare providers with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of investigational treatments. In addition, lawsuits against physicians who comply with terms specified in HB584 are prohibited. The legislation also prohibits an official, agent or employee of the state from blocking access to an experimental treatment.
Thirty-seven states have approve Right to Try. 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.