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 also protected under the bills, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB2300 reads, in part:
A health care practitioner who participates in administering a treatment described in section 3 of this 2015 Act, or a health care facility or professional organization or association involved in the administration of the treatment, is not subject to civil or criminal liability for acts or omissions of acts related to administering the treatment…
A licensing board, health care facility, health care practitioner or professional organization or association may not subject a health care practitioner to discipline, including suspension, loss of license, loss of privileges, loss of membership or any other penalty, for participating in administering a treatment.
However, HB2300 does contain a provision limiting patient access to experimental medicines and procedures. Patients are only be eligible for the experimental medicines and procedures after it is determined that they only have six months to live. Other states have passed this type of legislation without these restrictive provisions.
Nevertheless, HB2300 is an important step in the right direction toward health freedom. Oregon is now the twenty-fourth state to embrace this type of reform with more than 20 states introducing such measures this year alone.
“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.”
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.
The new law goes into effect on Jan. 1, 2016.