March 25, 2015 – Yesterday, Governors in Utah and Indiana signed bills known as the “Right to Try Act.” The new laws effectively nullify in practice some FDA restrictions which prevent terminally ill patients from accessing treatments. on terminally-ill patients. They join seven other states that have already done the same.

Indiana House Bill 1065 (HB1065), introduced by Rep. Wes Culver, and UtahHouse Bill 94 (HB94) introduced by Rep. Gage Froerer, represent the latest pushback against the FDA and their controversial methodology of withholding experimental treatments from people even on their deathbed.

In Indiana, HB1065 passed 50-0 in the Senate and 92-0 in the House. In Utah, HB94 passed 26-0 in the Senate and 69-3 in the House

With the new laws, a patient suffering from a terminal disease attested to by a physician and who has considered all other approved treatment options will be able to try experimental treatments or drugs not yet approved by the FDA, effectively nullifying this narrow, but important set of federal restrictions.

Like 5 year old Jordan McLinn, who has Duchenne muscular dystrophy, or DMD, a muscle weakening disorder. It is fatal. Kids born with DMD are often wheelchair-bound by age 12, with a life expectancy of just 25 years. In December, he became an honorary member of two Indiana fire departments.

According to a report in CBS News, “There are no approved therapies for Jordan’s condition, but his mother says a drug in development has had promising preliminary results in cases similar to his.”

“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.”

Physicians and pharmacists are also protected under the bills, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. HB1065 reads, in part:

This section does not create a cause of action against a health care provider involved in connection with the use of an investigational drug, biological product, or device by a patient for any harm to the patient from the investigational drug, biological product, or device

These bills make up part of a greater trend sweeping the nation. During this most recent November election, Arizona residents approved Prop. 303, known as the Arizona Terminal Patients’ Right to Try Referendum. The proposition allows investigational drugs, biological products or devices to be made available to eligible terminally ill patients, not permitted under the FDA.

Legislatures in Colorado, Michigan, Missouri, WyomingArkansas, and Louisiana, have already passed Right to Try Laws similar to the Arizona amendment, 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.


Track the status of similar legislation and take action in support at THIS LINK

Michael Boldin

The 10th Amendment

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