LANSING, Mich. (Feb. 11, 2022) – Yesterday, a Michigan House committee passed a bill that would expand the state’s “Right to Try” law to allow patients to try a broad range of treatments for COVID-19.
Rep. Mary Whiteford (R) introduced House Bill 5637 (HB5637) on Dec. 14. The proposed law would expand the state’s Right to Try law to allow a patient to try “a drug, biological product, device, or other treatment, that remains under investigation in a United States Food and Drug Administration-approved clinical trial” and that a physician recommends as a remedy for COVID-19, or a drug, biological product, or device normally prescribed as a remedy to treat an illness other than COVID that a physician recommends as a remedy for coronavirus.
During the coronavirus pandemic, the FDA effectively blocked the use of some treatments for coronavirus, including ivermectin and chloroquine. The passage of HB5637 would open the door for doctors to prescribe such treatments in Michigan.
HB5637 builds on the Michigan Right to Try law.
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.
HB5637 will now move to the full House for further consideration.