BURSTSen. Jim Banks (R-Ind.) wants the Food and Drug Administration to look into foreign-made active pharmaceutical ingredients he says are being included in online weight loss drugs.
In a letter to acting FDA Commissioner Sara Brenner, Banks warned that the nation is seeing a spike in drugs with the foreign-made ingredients that could post health risks for Americans purchasing them online.
“Booming online gray and black markets are flooding the country with knock-off and counterfeit GLP-1s contaminated with foreign-made APIs [active pharmaceutical ingredients], and few Americans purchasing these drugs are aware of the risks they pose,” Banks wrote in the Wednesday letter.
“I request detailed information about how the Food and Drug Administration (FDA) will prevent unlawful APIs from entering the country and potentially harming Americans,” he added.
GLP-1s refers to compounded glucagon-like peptide 1 agonist medications -- injectable weight-loss drugs.
Banks in the letter said the FDA's Adverse Event Reporting System database as of the end of last year had recorded more than 900 cases of adverse health events associated with the matter, which he said was four times the number see in the 2022 fiscal year. Seventeen of those cases involved deaths, Banks wrote.
Banks wrote that faulty medications were entering the country due to a lack of FDA assessment at points of entry.
“These drugs come in formulations that the FDA has never approved, have inconsistent doses, misrepresent injectable insulin as semaglutide, contain contaminants, or are in reality completely different drugs,” the Indiana senator said.
Those selling such drugs must be shut down he added.
Banks’s letter to Brenner asks how the FDA will work with U.S. Customs and Border Protection to prevent counterfeit drugs from entering the United States while educating communities about the difference between authentic and knock off drugs.
The Hill has reached out to the FDA for comment.