ANNAPOLIS, Md. (Dec. 30, 2015) – Two bills prefiled for the 2016 session in the Maryland legislature would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Sen. Bryan Simonaire (R – Dist. 31) prefiled Senate Bill 63 (SB63) over the summer. Del. Karen Young (D – Dist. 3A) will sponsor House Bill 56 (HB56), a companion bill in the House. 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,” SB63 and HB56 would bypasses the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without first getting FDA approval in Maryland. They 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…