AUSTIN, Tex. (Apr. 23, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally-ill patients from accessing treatments unanimously passed the Texas state House yesterday. The vote was 145-0.
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.
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.”
Health care providers are also protected under the bills, 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. HB21 reads, in part:
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.
Similar to a bill passed in the state Senate this month, the legislation also bars state-level interference in patients receiving access to experimental treatments and procedures saying, “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.”
Introduced by State Sen. Paul Bettencourt (R-Houston) along with 23 bipartisan co-sponsors, Senate Bill 694 (SB694) passed the state Senate unanimously with a 31-0 vote on April 9.
Legislatures in 15 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.
Now that HB21 and SB694 have passed their first chamber, the other chamber must concur before sending the legislation to the Governor’s desk.
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.
