A bill filed in the Montana State Legislature week would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.
Introduced by State Sen. Cary Smith, Senate Bill 142 (SB142) is the latest pushback against the FDA and their controversial methodology of approving drugs for mass consumption.
It would allow a manufacturer of an investigational drug available to an eligible patient who has requested the drug it with or without compensation, albeit they are not required to provide it. The patient would have to have a terminal illness and have considered all other treatment options currently approved by the United States food and drug administration. Additionally, they would have to receive a recommendation from the patient’s treating health care provider and be given written consent.
The bill would create requirements for the patient before they could use the experimental drugs, including an explanation of the currently approved products and treatments for the disease or condition they suffer from and a description of the potentially best and worst outcomes of using the drug. The description of the outcomes would have to include the following:
The possibility that new, unanticipated, different, or worse symptoms might result and that the proposed treatment could hasten death; and be based on the treating health care provider’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition.
The bill is a part of a greater trend promoting medical freedom that is 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, which are not permitted under the FDA. Prop. 303 is similar to laws passed in Colorado, Michigan, Missouri, and Louisiana, known as “Right to Try” laws.
These laws, though they deal with a small aspect of the FDA’s regulations, provides us with a clear model of how to nullify federal laws that violate the Constitution by narrowing the influence of nullification to limited aspects of the law itself.
The effectiveness of such nullification laws rests in the obvious logic behind them; 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 have 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.
These types of laws are necessary because of the cumbersome bureaucratic process deployed by the FDA. 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.
One such example is that of Mikaela Knapp, who was diagnosed with kidney cancer.
According to a World Net Daily report:
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.
Under a free market (and if the feds adhered to the Constitution) the therapy would have been available for Knapp already. She would not have had to seek anyone’s permission, which she died waiting for.
This is simply unacceptable. Whatever the dangers inherent in trying experiment drugs, this is a decision that should rest solely with the person consuming the drug, not busybodies, do-gooders, or sanctimonious control freaks.
There may be those who reject the nullification method and opt instead to work within the system in D.C., but they shouldn’t get their hopes up. 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.
That is why bills such as SB142 are so important. Because federal regulatory agencies and courts refuse to show compassion for terminally ill patients, we must step up at the state level to help them. It is truly a matter of life and death.
SB142 has been assigned to the Senate Public Health, Welfare and Safety committee, where it will need to pass by a majority vote before the full senate can consider it.
ACTION ITEMS
In Montana: 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.
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