ANNAPOLIS, Md. (March 21, 2017) – Yesterday, the Maryland House unanimously passed a bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Introduced by Del. Karen Young (D-Frederick) and 18 bipartisan co-sponsors, House Bill 584 (HB584) would give terminally ill patients access to medicines and treatments not yet 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.
HB584 creates a process to bypass the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.
HB584 passed the House by a 139-0 vote.
The proposed law includes protections for healthcare providers with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of investigational treatments. In addition, lawsuits against physicians who comply with terms specified in HB584 would be prohibited. The legislation would also prohibit an official, agent or employee of the state from blocking access to an experimental treatment.
Currently, 33 states have Right to Try laws on the books. Although these laws 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.
“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 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.
HB584 now moves to the Senate for further consideration. It was referred to the Senate Finance Committee where it must pass by a majority vote before moving forward in the legislative process.