AUSTIN, Dec. 4, 2014 – A bill prefiled in Texas this week would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.
House Bill 438 (HB438), the Right to Try Act, authored by Rep. Terry Canales (D-Edinburg), is the latest pushback against the FDA and their controversial methodology of approving drugs for mass consumption.
Under HB438, “A patient is eligible to access and use an investigational drug, biological product” as long as they have “a terminal condition, attested to by the patient’s treating physician.” The term ‘investigational drug’ refers to drugs that have not been approved by the FDA for mass consumption.
A patient qualifies for investigational drugs under HB438 if they are “unable to participate in a clinical trial of the recommended investigational drug, biological product, or device within 100 miles of the patient’s home address” or if they have “not been accepted to the clinical trial before the eighth calendar day after the patient completed the application process for the trial.” If they qualify and sign a waiver, patients can sidestep federal regulations to receive potentially life-saving medication and treatment.
HB438 is apart 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 HB438 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.
For Texas: Contact your State House Representative and politely urge them to co-sponsor HB438. Afterwards, contact your State Senator and politely urge them to introduce similar legislation to HB438 in their chamber. Feel free to contact more of your state legislators and urge them to co-sponsor and support HB438 as well. You can find their contact information HERE.
For other states: Contact your state legislators and urge them to introduce ‘Right to Try’ legislation similar to HB438 in Texas. You can find their contact information HERE.