JUNEAU, Alaska – (April 14, 2016) – A second Alaska Senate Committee has 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.
Sen. Bill Wielechowski introduced Senate bill 113 (SB113) in April of last year.The legislation would give terminally ill patients access to medicines not yet given final approval for use by the FDA.
SB113 unanimously passed the Senate Judiciary Committee with all three members recommending “do-pass.” Last month, SB113 cleared the Senate Health and Social Services Committee The bill now moves on to the Rules Committee 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.
SB113 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. They are shielded from lawsuits as well. SB113 reads, in part:
A person is not liable in an action for damages for the injury or death of a patient with a terminal illness resulting from the patient’s use of an investigational drug, biological product, or device if the person acting in good faith and with reasonable care is a
(1) physician who prescribed, dispensed, or administered the investigational drug, biological product, or device to the patient and… obtained the informed consent of the patient in writing after presenting to the patient all treatment options currently approved by the United States Food and Drug Administration for treatment of the patient’s terminal illness; and provided written notice of the immunity provided under this section to the patient; or
(2) manufacturer, importer, or distributor of the investigational drug, biological product, or device and… presented to the physician all treatment options currently approved by the United States Food and Drug Administration for treatment of the patient’s terminal illness and provided written notice of the immunity provided under this section to the patient.
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.
Alaska looks to join 26 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.
The Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.
For Alaska: 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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