CHARLESTON, Wv. (Feb. 2, 2016) – A West Virginia bill introduced last week 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.
House Bill 2026 (HB2026) by would give terminally ill patients access to medicines not yet 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.
HB2026 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.
“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.”
The law also provides protection to health care providers, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB2026 reads, in part:
Notwithstanding any other law, a licensing board may not revoke, fail to renew, suspend or take any action against a health care provider’s license…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, as long as the recommendations are consistent with medical standards of care. 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 is prohibited.
In addition, lawsuits against physicians who comply under the terms specified in HB2026 are prohibited:
This article does not create a private 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 using the investigational drug, biological product or device, for any harm done to the eligible patient resulting from the investigational drug, biological product or device, so long as the manufacturer or other person or entity is complying in good faith with the terms of this article, unless there was a failure to exercise reasonable care.
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.”
West Virginia 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.
HB2026 was referred to the Judiciary Committee. The committee must approve the bill before it can receive a full House vote.
ACTION ITEMS
For West Virginia: Support this bill by following all the steps at THIS LINK.
For other states: Take action to support Right to Try at this link.
- Kentucky Second Amendment Privacy Act Passed as Law - March 27, 2024
- Wyoming Governor Signs Second Amendment Financial Privacy Act into Law - March 26, 2024
- Tennessee Senate Passes Second Amendment Financial Privacy Act - March 25, 2024