ANNAPOLIS, Md. (Feb. 6, 2017) – A bill introduced in the Maryland House would 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 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.

The law also provides protection to health care providers, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB584 reads, in part:

A health occupations board may 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 recommendation to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, provided the recommendation is consistent with medical standards of care… The department may not take action against a health care provider’s medicare certification based solely on the health care provider’s recommendation that an eligible patient have access to an investigational drug, biological product, or device.

In addition, lawsuits against physicians who comply under the terms specified in HB584 are prohibited:

This… does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against another person involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm to the eligible patient resulting from the investigational drug, biological product, or device if the manufacturer or other person is complying in good faith with this subtitle and has exercised reasonable care.

Maryland could join 33 states with a 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.

NEXT UP

HB584 was referred to the House Health and Government Operations Committee. The committee must approve the bill before it can receive a full House vote.