HARTFORD, Conn. (June 22, 2016) – Connecticut Gov. Daniel Malloy’ has signed a bill into law that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
The Joint Insurance and Real Estate Committee introduced what would become Senate Bill 371 (SB371) in March, The legislation enables terminally ill patients to access medications and treatments not yet given final approval for use by the FDA.
The Senate unanimously passed SB371 36-0 on May 3. With the session winding down, the House approved the measure the next day 122-19. With Gov. Malloy’s signature, the law will go into effect on Oct. 1
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.
The new Connecticut Right to Try law 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.
Physicians who prescribe these drugs and procedures to patients are shielded from liability under the law.
“Notwithstanding the provisions of chapter 370 of the general statutes, the Department of Public Health or the Connecticut Medical Examining Board shall not revoke, fail to renew, suspend or take any disciplinary action against a physician based solely on the treating physician’s recommendation to a patient regarding access to, or treatment with, an investigational drug, biological product or device, provided such recommendation is consistent with medical standards of care.”
The manufacturers of such experimental treatments enjoy similar protection under the new law.
SB371 further declares, “No official, employee or agent of the state shall prevent, or attempt to prevent, a patient who is eligible…from accessing an investigational drug, biological product or device.”
“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.”
So far, more than two-dozen 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.
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