New Jersey bill introduced last week 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.
Assembly Bill 1455 (A1455) by would allow terminally ill patients to 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.
A1455 would bypass the FDA expanded access program and allow 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.
“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 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. AB1455 reads, in part:
The bill would prohibit the State Board of Medical Examiners from revoking a license, failing to renew a license, or taking any other disciplinary action against a physician solely based on the physician’s recommendation, prescription, or treatment of an eligible patient with an investigational drug, biological product, or device consistent with the provisions of the bill.
The manufacturer would be permitted to provide the investigational drug without compensation or require the patient pay the costs associated with it. Government medical assistance programs and private health insurers would not be required to provide coverage for the cost but private insurers would be allowed to cover it if they want.
Any attempt to prevent a terminally ill patient from obtaining experiment drugs would punishable by imprisonment for up to six months, a $1,000 fine, or both.
Although these type of 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,” 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.”
New Jersey looks to join twenty-four other states that have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.
A1455 was referred to Assembly Health and Senior Services Committee.
For New Jersey: Support this bill by following all the steps at THIS LINK.
For other states: Take action to support Right to Try at this link.
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