A bill filed in the California Assembly would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.

Introduced by Asm. Ian Calderon, Assembly Bill 159 (AB159) serves as the latest pushback against the FDA and its controversial methodology of approving drugs for mass consumption.

If passed, the bill would allow for eligible patients with terminal illnesses to use investigational drug. The bill would also allow, but not require, a health benefit plan to provide coverage for these investigational drugs. A terminal illness is defined by the bill as “a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.”

The bill would also specifically prohibit the Medical Board of California and the Osteopathic Medical Board of California from taking any “disciplinary action against the license of a physician based solely on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug…provided that the recommendation or prescription is consistent with medical standards of care.”

The bill would also protect health care providers from legal action, specifically any state agency from altering any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program. State employees would also be prohibited from trying to stop an eligible patient from using an investigational drug.

The bill is similar in scope to what California voters passed in 1996, with the Compassionate Use Act. That bill started what some call the modern nullification movement by authorizing the use of marijuana for limited medical purposes in defiance of federal prohibition.

“California started a trend that is bringing down federal prohibition without waiting for Congress to do so,” said Michael Boldin of the Tenth Amendment Center. “By following up on the fives states that have already passed Right to Try Acts, California can help do the same, help sick people and nullify, in practice, more federal restrictions that hurt people.”

AB159 makes up part of a greater trend promoting medical freedom 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 ColoradoMichiganMissouri, and Louisiana, have already passed Right to Try Laws similar to the Arizona amendment. More than twenty states are considering such bills for 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.

Dying people should not be deprived of their right to any means that might ease their pain or keep them alive, and it is extremely difficult for opponents to argue that dying people should be forced to use only drugs approved of by bureaucrats who are incapable of empathizing with their possible suffering.

In Louisiana, for example, the law received 80 percent approval, according to one survey. In three of the states that passed “Right to Try” laws, not a single politician voted nay. In Michigan, the entire state House voted yea with no abstentions, while only two senators voted against it.

The cumbersome bureaucratic process deployed by the FDA makes Right to Try laws necessary. It can take more than a decade and a billion dollars to get new medications on the market, according to Lucy Caldwell, communications director for the Goldwater Institute.

Mikaela Knapp provides a compelling real-life example.

According to a World Net Daily report when Knapp was diagnosed with kidney cancer, she and her husband, Keith, launched a social media campaign to lobby drug firms and the FDA to give her access to a new gene therapy. Their efforts gained national attention and generated 200,000 signatures on a petition at Change.org but failed to win access to the treatment. The 25-year-old newlywed died April 24.

The ugly truth is she died waiting for somebody’s permission that never came.

This serves as yet another example of failure in Washington D.C. The FDA shows no inclination to change its rules, and Congress has not made any move to loosen restrictions, despite countless stories like Knapp’s The courts haven’t helped either. In 2003, a federal judge ruled that terminally ill people do not have a right to access to investigational medicine. Not surprisingly, the U.S. Supreme Court declined to consider an appeal on that ruling.

The fact that federal regulatory agencies and federal courts refuse to show compassion for terminally ill patients make state Right to Try bills crucial. AB159 would bypass stubborn federal bureaucrats and give hope to those suffering from terminal illness.

The bill is expected to be referred to a committee by Feb. 22

ACTION ITEMS

In California: 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.

TJ Martinell

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