HARRISBURG, Pa. (May 11, 2015) – A bill filed in the Pennsylvania state House last week would effectively nullify in practice some Food and Drug Administration (FDA) rules that prevent certain treatments from being used by terminally-ill patients.
Introduced by Rep. Robert Godshall (R-Montgomery) on May 4 and 21 bipartisan co-sponsors, House Bill 1104 (HB1104), the Pennsylvania Right to Try Act, pushes 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. HB1104 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 bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB1104 reads, in part:
No physician who in good faith recommends or participates in the use of an investigational drug, biological product or device under this act shall be subject to criminal or civil liability, nor shall a physician be found to have committed an act of unprofessional conduct…
The State Board of Medicine and the State Board of Osteopathic Medicine may not revoke, suspend or otherwise take any action against an individual holding a license… based solely on the individual’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product or device, as long as the recommendations are consistent with medical standards of care.
In addition, caregivers are protected from lawsuits if harm is caused from the lawful administration of experimental medicines and procedures under this bill “except when the injury results from a failure to exercise reasonable care.”
HB1104 is an important step in the right direction toward health freedom. Legislatures in sixteen other states have already passed Right to Try Laws similar to this Pennsylvania 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.
HB1104 was referred to the House Health Committee. It must pass through this committee assignment successfully before it can receive a full vote in the state House.
ACTION ITEMS
For Pennsylvania: Take steps to support HB1104 at THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at this link.
