PROVIDENCE, R.I. (June 20, 2015) – This week, the Rhode Island state House unanimously approved a bill that would effectively nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing experimental treatments. The vote was 72-0.
Introduced by Rep. Joseph McNamara and four co-sponsors in January, House Bill 5093 (H5093) gives terminally ill patients access to medicines that have not been given final approval for use by the FDA. The state House approved the bill unanimously on June 17 with a 72-0 vote. The state Senate now must concur with this decision before the bill can be placed on the Governor’s desk.
“States are taking the lead in an area where the federal government is slow to respond,” Rep. McNamara said in a Providence Journal article. “One of the greatest attributes of this bill is that it will provide some hope for people.”
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. H5093 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 bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are protected from lawsuits as well. H5093 reads, in part:
A licensing board or disciplinary subcommittee shall not 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 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 chapter does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient… for any harm… if the manufacturer or other person or entity is complying in good faith… and has exercised reasonable care.
In addition, state officials are now barred from unlawfully interfering in the process of patients receiving experimental drugs and procedures. H5093 reads, in part:
An official, employee, or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device. Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section.
H5093 is an important step in the right direction toward health freedom. Rhode Island has the opportunity to join nineteen other states who have ‘Right to Try’ laws on the books. In addition, more than 20 states have introduced such measures in 2015.
“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.
ACTION ITEMS
For Rhode Island: Take steps to support this bill at THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at THIS LINK.
