By Tenth Amendment Center Blog
TALLAHASSEE, Fla. (Jan. 17, 2015) – A bill filed in the Florida House this week would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.
Rep. Ray Pilon (R-Sarasota) introduced the Florida Right to Try Act on Jan. 14. HB269 serves as the latest pushback against the FDA and its controversial methodology of approving drugs for mass consumption.
If passed, a patient suffering from a terminal disease attested to by a physician and who has considered all other approved treatment options would be able to try experimental treatments or drugs not yet approved by the FDA. The patient must give written, informed consent before undergoing the treatment, and the legislation provides an extensive definition of “informed consent. The legislation stipulates that “a manufacturer is not required to make an investigational drug, biological product, or device available to a patient,” and provides legal protections for medical professionals and manufacturers.
HB269 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.
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 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. HB269 would bypass stubborn federal bureaucrats and open give hope to those suffering from terminal illness.
The bill has yet to be assigned to a committee.