PROVIDENCE, R.I. (May 11, 2018) – On Wednesday, a Rhode Island House committee passed a bill would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Rep. Joseph McNamara (D-Warwick) introduced House Bill 7294 (H7294) in January along with four bipartisan co-sponsors. The legislation would allow terminally ill patients access to medicines and treatments not yet given final approval for use by the FDA.
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.
HB7294 creates a process to bypass the FDA expanded access program and allows 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.
The House Committee on Health Education and Welfare recommended H7294 for passage.
The bill is titled the “Neil Fachon Terminally Ill Patients’ Right To Try Act Of 2018.” Fachon was diagnosed with …
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