MADISON, Wis. (Apr. 28, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was introduce in the Wisconsin state Senate last week.
Introduced by State Senator Fred Risser (R-Andover) on April 20 along with 32 bipartisan co-sponsors, Senate Bill 125 (SB125) pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. SB125 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and effectively nullifies it in practice.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “When someone is on their deathbed, the fact that FDA regulations would let them die rather than try, has got to be one of the most inhumane policies of the federal government. Every state should nullify the FDA like this.”
In addition to authorizing use, state officials are barred from unlawfully interfering in the process of patients receiving experimental drugs and procedures under SB125. It states that “no official, employee, or agent of this state may block or attempt to block an eligible patient’s access to an investigational drug, device, or biological product. ”
Health care providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. They are also protected from lawsuits. SB125 reads, in part:
A physician is immune from civil or criminal liability or professional discipline based solely on the physician’s recommendation to an eligible patient for the use of an investigational drug, device, or biological product to treat the patient’s terminal illness if the eligible patient gives written informed consent…
Any manufacturer, distributor, pharmacist, practitioner, or other person who lawfully makes available, delivers, distributes, prescribes, dispenses, or administers an investigational drug, device, or biological product to an eligible patient consistent with this section, and who in doing so exercises reasonable care, may not be held liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from any of the following:
1. The design, development, clinical testing, investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of the investigational drug, device, or biological product.
2. The lack of safety or effectiveness of the investigational drug, device, or biological product.
SB125 is an important step in the right direction toward health freedom. Legislatures in fifteen other states have already passed Right to Try Laws similar to this Wisconsin bill, and more than 20 states are considering such measures in 2015.
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.
SB125 must pass through the Health and Human Services Committee successfully before it can receive a full vote in the state Senate.
For Wisconsin: Take steps to support SB125 at THIS LINK.
For other states: Take the steps to get a similar bill passed in your state at this link.