A bill prefiled in West Virginia this week would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.
House Bill 2026 (HB2026), the Right to Try Act, marks the latest measure of pushback against the FDA and their controversial methodology of approving drugs for mass consumption.
The bill was introduced on Jan. 14 and has already received immense bipartisan support. Delegates Gary G. Howell (R-Mineral), Ray Canterbury (R-Greenbrier), Danny Hamrick (R-Harrison), George Ambler (R-Greenbrier), Mark Zatezalo (R-Hancock), John McCuskey (R-Kanawha), Paul Espinosa (R-Jefferson), Scott Cadle (R-Mason), David Evans (R-Marshall), Ruth Rowan (R-Hampshire) and William G. Hartman (D-Randolph) have already signed on to co-sponsor the HB2026. The bill is now in the House Committee on Health and Human Resources pending approval before it can receive a full house vote.
Under HB2026, “a manufacturer of an investigational drug, biological product or device may make available” medical treatment that has yet to be approved federally to “eligible patients” who have “considered all other treatment options currently approved by the United States Food and Drug Administration” and “been unable to participate in a clinical trial for the terminal illness within one hundred miles of the patient’s home address for the terminal illness, or not been accepted to the clinical trial within one week of completion of the clinical trial application process.”
Other requirements needed to receive experimental medical treatment under HB2026 include “written, informed consent for the use of the investigational drug, biological product or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written, informed consent on the patient’s behalf” as well as “a recommendation from his or her physician” and “documentation from his or her physician that he or she meets the requirements” listed in the bill. Insurers are not required to cover these types of treatments under the bill.
Health care providers who prescribe these drugs to patients are shielded from liability under HB2026. The bill states that “a licensing board may not revoke, fail to renew, suspend or take any action against a health care provider’s license… based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product or device, as long as the recommendations are consistent with medical standards of care. Action against a health care provider’s medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product or device is prohibited.”
HB2026 keeps state officials from getting in the way of patients receiving these medications. The bill states that “an official, employee or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product or device.” In addition, the bill “does not create a private cause of action against a manufacturer… involved in the care of an eligible patient using the investigational drug, biological product or device, for any harm done to the eligible patient… so long as the manufacturer or other person or entity is complying in good faith with the terms of this article, unless there was a failure to exercise reasonable care.”
HB2026 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. HB2026 would bypass stubborn federal bureaucrats and give hope to those suffering from terminal illness.
For West Virginia: Support this bill by following all the action steps at THIS LINK
For other states: Take action to support this legislation in your state at this link.