MONTIPELER, Vt. (Dec. 22, 2015) – A bill introduced in the Vermont Senate would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Sen. Dick McCormack (D-Windsor) prefiled Senate Bill 258 (S.258) for the 2016 session. The legislation would give terminally ill patients access to medicines and treatments that have not received final approval for use by the FDA, nullifying in practice some federal rules that stop patients from utilizing such treatments.
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.
Titled the “Right to Try Act,” S.258 would bypasses the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without first getting FDA approval. It also would prohibit any state agency from blocking patient access to such treatment. 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.”
S.258 also provides legal protection for…