‘Last week, Georgia Gov. Nathan Deal signed a bill into law 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.
Rep. Mike Dudgeon (R-Johns Creek) introduced House Bill 34 (HB34). The new law enables terminally ill patients to access to medications 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.
HB34 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.
Physicians who prescribe these drugs and procedures to patients are shielded from liability under the law. The statute states that “the Georgia Composite Medical Board shall not revoke, suspend, sanction, fail to renew, or take any other action against a physician’s license solely based on such physician’s recommendation, prescription, or treatment of an eligible patient with an investigational drug, biological product, or device pursuant to this chapter.”
The manufacturers of such experimental treatments enjoy similar protection under the new law.
HB34 further declares that “no official, employee, or agent of the state shall block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”‘