SPRINGFIELD, Il. (Aug. 11, 2015) Last week, Gov. Rauner signed a bill into law to nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments.
Introduced by Rep. Greg Harris (R-13) and 21 bipartisan co-sponsors, House Bill 1335 (HB1335) gives terminally ill patients access to medicines that have not been 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. HB1335 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.
HB1335 had previously passed in the state House on April 15 by a 114-1 vote. It passed in the state House on May 19 by a unanimous 55-0 vote. It was officially signed into law by Gov. Rauner on Aug. 5 and will go into effect next year.
“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.”