AUSTIN, Tex. (May 25, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally-ill patients from accessing treatments was given final approval by the state House and Senate over the weekend.
Introduced by State Rep. Kyle Facal (R-Brazos) along with 121 bipartisan co-sponsors, House Bill 21 (HB21), known as the Right to Try Act, would give terminally-ill patients access to medicines that have not been given final approval for use by the FDA. It reads, in part:
…The use of available investigational drugs, biological products, and devices is a decision that should be made by the patient with a terminal illness in consultation with the patient’s physician to pursue the preservation of the patient’s own life and is not a decision to be made by the government [emphasis added]
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. HB21 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and effectively nullifies it in practice.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “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 nullify the FDA like this.”
ADDITIONAL PROTECTIONS
The bill prohibits state officials from any actions that would prevent the lawful administering of experimental procedures to eligible patients. It reads, in part:
“An official, employee, or agent of this state may not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”
This is important, since local law enforcement often works closely with federal agencies to take aggressive actions to stop state program that aren’t in line with federal law.
“Including this provision ensures that the ‘boots on the ground’ for law enforcement – the locals, won’t be taking any action to stop sick people from trying new treatments. The feds will have to handle it, and they don’t have the manpower or resources to get the job done,” said Boldin.
Health care providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are shielded from legal recourse as well.
This [Act] does not create a private or state 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… for any harm done to the eligible patient resulting from the investigational drug, biological product, or device…
the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician’s license… based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, provided that the care provided or recommendations made to the patient meet the standard of care and the requirements of this chapter.
Legislatures in 17 other states have already passed Right to Try Laws similar to this Texas bill, and more than 20 states are considering such measures in 2015.
Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself. The strategy works because it focuses on ending specific federal policies large numbers of Americans from across the political spectrum oppose.
HB21 now moves to the Governor’s desk, where Greg Abbott will have up to 20 days to sign or veto.
ACTION ITEMS
For Texas: Take steps to support this important bill at THIS LINK
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.
