MONTGOMERY, Ala. (June 8, 2015) – An Alabama bill to effectively nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments has officially become law.
Senate Bill 357 (SB357) was introduced by State Senator Cam Ward (R-Alabaster) in April along with five co-sponsors. Gabe’s Right to Try Act gives terminally ill patients access to medicines that have not been given final approval for use by the FDA.
The bill’s title was inspired by Gabe Griffin, a nine year old child suffering from Duchenne Muscular Dystrophy (DMD). This rare, debilitating condition has had a 100 percent mortality rate up to this point. Gabe’s parents are hoping that SB357 will give their son a new lease on life.
“At 10 years old, Gabe walks, hugs, breathes, and feeds himself like any other typical child that age, but that will be taken away in the next few years if we don’t find a cure,” Gabe’s father, Scott Griffin said in a WTVY report. “Without a cure, Gabe is expected by doctors to be in a wheelchair by the time he is 12 years old and lose his life around the age of 20. Traci and I are willing to accept all risks to save our son and we will do anything to keep from having to put him in a wheelchair in a couple of years.”
SB357 had previously passed in the state Senate unanimously on April 30 by a 29-0 vote, and then passed in the state House unanimously on May 28 by a 97-0 vote. Having passed both chambers successfully, the bill became Act No. 2015-320 and is now officially the law of the land in Alabama.
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. SB357 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.
“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.”
Health care providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are also protected from lawsuits. SB357 reads, in part:
A licensing board or disciplinary subcommittee shall not issue a letter of concern or similar form of reprimand, nor revoke, fail to renew, suspend, or take any action against a health care provider’s license… based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. An entity responsible for Medicare certification shall not reprimand or take action against a health care provider’s Medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device…
This act does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any licensed health care provider, other person, or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this act, unless there was a failure to exercise reasonable care.
In addition, state officials are barred from unlawfully interfering in the process of patients receiving experimental drugs and procedures under SB357. The bill mandates that state officials “shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”