RALEIGH, N.C. (Sept. 30, 2015) – Patients facing life-threatening illnesses will have more treatment options open to them in North Carolina thanks to new a new law that tears down federal roadblocks that goes into effect Thursday.
The new “Right to Try” law sets the state to nullify in practice some Food and Drug Administration (FDA) rules that stop terminally ill patients from utilizing certain treatments by allowing them to access experimental medications and procedures not yet approved by the federal regulatory agency.
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.
Introduced by State Reps. Hugh Blackwell (R-Burke), Mike Hager (R-Rutherford), Donny Lambeth (R-Forsyth) and Robert T. Reives (D-Chatman) along with 22 bipartisan co-sponsors, House Bill 652 (H652) gives terminally ill patients access to medicines that have not received final approval for use by the FDA.
H652 passed unanimously in both the North Carolina House and Senate.
“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.”
The new North Carolina law bypasses the FDA expanded access program…