Tenth Amendment Center: Rhode Island Right to Try Act Would Reject Some FDA Restrictions on Terminal Patients
PROVIDENCE, R.I. (Jan. 31, 2018) – A bill introduced in the Rhode Island House would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Rep. Joseph McNamara (D-Warwick) introduced House Bill 7294 (H7294) with four bipartisan co-sponsors. The legislation would allow terminally ill patients access to medicines and treatments not yet given final approval for use by the FDA.
The bill is named the “Neil Fachon Terminally Ill Patients’ Right To Try Act Of 2018.” Fachon was diagnosed with diffuse intrinsic pontine glioma, a brain stem tumor that took his life in February 2017. He had to go to court to guarantee access to experimental medical treatments banned by the FDA. HB7294 would eliminate headaches for terminally-ill patients in receiving care that could save or extend their lives.
“The one thing everyone tries to hold onto is hope — hope that the individual will get well, hope that some procedure will lead to a cure,” Rep. McNamara said. “I want Rhode Island to do all it can to give these people hope. I want Rhode Island to give terminally ill patients the ‘right to try’ anything that might help them. Access to experimental treatments will provide terminally-ill patients with the fundamental right to control the decisions relating to their own medical care.”
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.
H7294 would create a process to 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.
Many states have already passed reforms similar to H7294, and the results show that 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.)
These bills 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 H7294 are prohibited.
Thirty-eight states have approved 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.
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H7294 must pass the House Health, Education and Welfare Committee before it can receive consideration in the full House.
Shane Trejo
January 31, 2018 at 12:53PM
