SALEM, Ore. (Aug. 17, 2015) – Last week, Gov. Brown signed a bill into law that sets the stage to nullify in practice some Food and Drug Administration (FDA) rules preventing terminally-ill patients from accessing experimental treatments.
Introduced at the request of House Interim Committee on Health Care, House Bill 2300 (HB2300) allows terminally ill patients access to medicines that have not been given final approval for use by the FDA. It passed unanimously in the House on Apr. 7 by a 59-0 vote. An amended version of the bill then passed unanimously in the Senate on July 1 by a 29-0 vote. It was signed into law by Gov. Brown on Aug. 12.
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. HB2300 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and effectively nullifies 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.”
Health care providers are…