ALBANY, N.Y. (Apr. 27, 2015) – Two bills that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments were introduced in the New York state legislature this month.
Assembly Bill 6889 (A6889) was introduced by Assemblymember Linda Rosenthal (D-Manhattan) along with 12 bipartisan co-sponsors while Senate Bill 4716 (S4716) was introduced by Senator Kemp Hannon (R-Nassau). These bills push back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
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. A6889 and S4716 bypass 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 in A6889 and S4716, with prohibitions in the bills against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are also protected from lawsuits. State officials are banned from interfering with qualifying patients accessing experimental treatments under the bills as well.
A6889 and S4716 are important steps in the right direction toward health freedom. Legislatures in fifteen other states have already passed Right to Try Laws similar to this Wisconsin 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 the bills have been introduced, A6889 must pass through the Assembly Health Committee and S4716 must pass through the Senate Health Committee before the bills can receive full votes in their respective chambers.
For New York: Take steps to support these bills at THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at this link.