MADISON, Wisc. (Feb. 28, 2022) – A bill introduced in the Wisconsin House would expand the state’s “Right to Try” law to include “off-label” treatments.
A coalition of three Republicans introduced House Bill 979 (AB979) on Feb. 15. Under the proposed law, patients with a life-threatening condition would be able to use “off-label” medications and therapies for treatment. The bill defines an off-label treatment as a drug, device, or biological product approved by the FDA for another use.
Doctors often discover that medications can treat conditions not originally part of the FDA approval process. For instance, Botox was originally approved to treat eye muscle disorders. Today it is used to treat a variety of conditions along with cosmetic applications. The FDA has generally allowed off-label drug use. But during the coronavirus pandemic, the FDA and federal government effectively blocked the use of some treatments for coronavirus, including ivermectin and chloroquine, even though the drugs were FDA approved for other conditions.
Passage of AB979 would ensure terminally ill patients could access any off-label treatments no matter what policies the FDA or federal government put in place.
AB979 builds on the Wisconsin Right to Try law passed in 2018.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs and treatments. 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. RIght to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA approval.
Congress passed a federal Right to Try law in 2018 after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
WHAT’S NEXT
AB979 was referred to the House Committee on Health. It must get a hearing and pass by a majority vote before moving forward in the legislative process.
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