RICHMOND, Va. (Feb 25, 2015) – By a 99-0 vote yesterday, the Virginia state House passed a bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients. If the Senate concurs, the bill will move to the Governor’s desk for a signature.
Introduced by Sen. William Stanley, Senate Bill 732 (SB732), the Virginia Right to Try Act, is the latest pushback against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
If passed into law, 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, effectively nullifying this narrow, but important set of federal restrictions.
Health care providers who prescribe these drugs to patients are shielded from liability under SB732. The updated text of the bill states that “no health care provider who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device to a person (under the bill)…shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds.”
SB732 makes up part of a greater trend 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 Colorado, Michigan, Missouri, and Louisiana, have already passed Right to Try Laws similar to the Arizona amendment, and more than 20 states are considering such measures in 2015, with legislative chambers in Utah, Montana, Wyoming, Arkansas and Mississippi passing similar measures this month.
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.
The original version of SB732 stated that “an individual who prevents or attempts to prevent a manufacturer from making an investigational drug, biological product, or device available to a person in accordance with the provisions of this section is guilty of a Class 1 misdemeanor.” This is a provision that has not been found in similar Right to Try bills that have been introduced and passed in other states. However, this clause was amended out on the House floor before passage.
SB732 now moves back to the state Senate, where the chamber will have an opportunity to accept or recent the amended House version. Should they reject and demand the slightly stronger Senate version of the bill, it will go back to the House for approval of that version. If the House rejects, the two chambers will hold a conference committee meeting to work out a middle ground. At any time in the process, should either chamber accept the other’s, it will go to the Governor’s desk for approval. At this stage, whatever the final form, the Virginia legislature has passed a positive first step to help terminally-ill patients from FDA restrictions that can kill.
ACTION ITEMS
Take the steps to get a similar bill passed in your state at this link.
NOTE: TJ Martinell contributed to this report.
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