In this episode of Thoughts from Maharrey Head, I talk to Robert Scott Bell about Right to Try legislation nullifying some FDA restrictions on terminally-ill patients.
In the last couple of years, 24 states have passed “Right to Try Legislation” that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
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.
Right to Try laws 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.
In this week’s episode of Thoughts from Maharrey Head, I talk to Robert Scott Bell, homeopathic practitioner and radio show host. Robert and I discuss Right to Try, why it matters and what’s next.
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