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.”
Health care providers are also protected under the new law, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB1335 reads, in part:
The Department shall not revoke, suspend, place on probation, reprimand, refuse to issue or renew, or take any other disciplinary or non-disciplinary action against the license or permit issued under this Act to practice medicine to a physician based solely upon the recommendation of the physician to an eligible patient regarding, or prescription for, or treatment with, an investigational drug, biological product, or device.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “When someone is on their deathbed, the fact that FDA regulations would let them die rather than try, has got to be one of the most inhumane policies of the federal government. Every state should nullify the FDA like this.”
HB1335 is an important step in the right direction toward health freedom. Illinois is now the twenty-third state to embrace this type of reform with more states expected in 2016.
Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself. The strategy works because it focuses on ending specific federal policies large numbers of Americans from across the political spectrum oppose.
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.