Idaho Legislators Defy the FDA, Houses Passes Right to Try Legislation
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The US Food and Drug Administration and its very foundation have been on the receiving end of heavy criticism for quite some time, and yet the agency’s power appears to never be brought into question in a significant way.
Frustration, however, is often the best incentive. With that in mind, a group of Idaho lawmakers decided to join several other states by defying the FDA’s powers by proposing a piece of legislation that would practically nullify some of the agency’s rules prohibiting terminally ill patients from having access to experimental treatments. The bill would allow Idaho residents to have access to these experimental treatments, regardless of what the FDA has to say on the matter.
According to the Tenth Amendment Center, the House of Delegates Health and Welfare Committee introduced House Bill 481 on February 12. On February 29, the bill passed the House by an overwhelming margin.
Access to experimental drugs and treatments is restricted under the Federal Food, Drug, and Cosmetic Act. While the law keeps the general public from having access to experimental drugs and treatments, a provision known as 21 U.S.C. 360bbb gives patients with serious or life-threatening diseases access to experimental drugs that have been approved by the FDA. Drugs that haven’t been approved by the agency, however, remain out of reach.
If HB 481 passes, the FDA’s rules would not apply to Idaho residents seeking access to experimental drugs. Instead, state laws would protect manufacturers and physicians involved in aiding the terminally ill. By protecting all parties involved from liabilities for their participation, the state may effectively nullify the FDA’s rules locally.
The bill states that eligible patients may “request, and a manufacturer may make available to an eligible patient under the supervision of the patient’s treating physician, the manufacturer’s investigational drug … which shall be clearly labeled as investigational; provided however, that this chapter does not require that a manufacturer make available an investigational drug to … an eligible patient.” With this piece of legislation in place, health care providers that agree to participate, whether by administering the treatment or by giving the patient the resources necessary to carry on with the experimental treatment, will be protected from possible legal actions. By protecting providers and physicians from sanctions, license troubles, or lawsuits, the state of Idaho joins other 24 states that have passed the “Right to Try” legislation in their states.
To the Tenth Amendment Center, this rapid evolution indicates that Americans of all walks of life are coming together to put an end to rules that put individuals in danger and that undermine their liberties.
HB 481 should move to the Idaho Senate for further consideration before the piece of legislation heads to the desk of Governor Butch Otter.