ANNAPOLIS, Md. (Dec. 30, 2015) – Two bills prefiled for the 2016 session in the Maryland legislature would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Sen. Bryan Simonaire (R – Dist. 31) prefiled Senate Bill 63 (SB63) over the summer. Del. Karen Young (D – Dist. 3A) will sponsor House Bill 56 (HB56), a companion bill in the House. The legislation would give terminally ill patients access to medicines and treatments that have not received final approval for use by the FDA, nullifying in practice some federal rules that stop patients from utilizing such treatments.
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.
Titled the “Right to Try Act,” SB63 and HB56 would bypasses the FDA expanded access program and allow patients to obtain experimental drugs from manufacturers without first getting FDA approval in Maryland. They also would prohibit any state agency from blocking patient access to such treatment. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify 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.”
The bills also provide legal protection for health care providers, including a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. The law would also shield doctors, along with manufacturers, from lawsuits arising from these experimental treatments.
So far, 24 other states have passed similar legislation into law. Although Right to Try bills only address one small aspect of FDA regulation, they provide a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.
The Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.
SB63 will be referred to the Senate Finance Committee once the regular session begins in January. HB56 will be referred to the Health and Government Operations Committee. Both bills will need to pass out of their respective committees with a majority vote before moving on to the full Senate and House for further consideration.
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