HARRISBURG, Pa. (June 22, 2016) – Last week, the Pennsylvania House unanimously passed a bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Rep. Robert Godshall (R-Montgomery), along with a coalition of 21 bipartisan co-sponsors, introduced House Bill 1104 (HB1104) last year. The legislation would give terminally ill patients access to medicines not yet given final approval for use by the FDA.
On June 15, the House approved the measure 182-0. It will now move over to the Senate for further consideration.
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 would 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.
Healthcare 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.”
“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.”
Although these type of bills 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.
Pennsylvania looks to join more than two-dozen other states that have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.
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