BOSTON (Mar. 8, 2015) – A bill introduced in Massachusetts would effectively nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments.
Rep. Nicholas Boldyga (R-Southwick) along with 36 bipartisan co-sponsors introduced House Bill 3270 (H3270) on Jan. 20. The Massachusetts Right to Try Act, pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
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. H3270 would bypass the FDA expanded access program and allow 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 also protected from lawsuits. H3270 reads, in part:
A regulating board… shall not revoke, fail to renew, suspend a license, or take any disciplinary action against a health care provider licensed by that board 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.
A health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device shall not affect medicare certification for that health care provider or the health care facility…
This section shall 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 done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this section and has exercised reasonable care.
“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.”
Legislatures in 13 other states have already passed Right to Try Laws similar to H3270, and more than 20 states are considering such measures in 2015.
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
In Massachusetts: Support this bill by following the action steps at THIS LINK.
In Other States: Take the steps to get a similar bill passed in your state at this link.
