COLUMBIA, S.C. (Feb. 29, 2016) – A South Carolina 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 unanimously passed the Senate last week.
Pre-filed on Dec. 2 by Rep. Paul G. Campbell (R-Berkeley), Senate Bill 929 (S.929) 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.
S.929 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.
The Senate passed the bill 41-0.
“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.”
S.929 would prohibit any state agency from interfering with access to experimental treatments.
“No official, employee, or agent of this State shall block or attempt to block an eligible patient’s lawful access to an investigational drug, biological product, or device.”
It would also provide protection to health care providers, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. The law also shields them from lawsuits. S.929 reads, in part:
A licensing board shall not revoke, fail to renew, suspend, or take any other disciplinary action against a health care provider licensed in this State, based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device…
An entity responsible for Medicare certification shall not take action against a health care provider’s Medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device…
No private right of action may be brought 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 caused… as long as the manufacturer or other person or entity has made a good-faith effort to comply with the provisions of this chapter.
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.
“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.”
South Carolina looks to join twenty-four 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.
S.929 will now move on to the House for further consideration.
In South Carolina: Support this bill by following all the steps at THIS LINK.
For other states: Take action to support Right to Try at this link.
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