Congress Probes Chinese Biotech GLP-1 Product Compliance

Congress Probes Chinese Biotech GLP-1 Product Compliance

Although the FDA recently implemented additional safeguards related to imported GLP-1 products,  the safety of GLP-1 active pharmaceutical ingredient (“API”) remains a key congressional focus.  Recently, Congressman Raja Krishnamoorthi announced that he sent formal letters to three biotechnology companies based in the People's Republic of China (PRC). The letters requested detailed information on the production, labeling, and export practices related to GLP-1 products and their APIs.

According to Congressman Krishnamoorthi’s press release, the inquiry stems from growing concerns over illicit manufacturing and the influx of unregulated, potentially counterfeit injectable drugs into the United States.

Each of the letters asks the companies to respond to the following questions which includes specific questions related to relationships with U.S.-based compounding companies:

1. Please provide a full list detailing all semaglutide and tirzepatide products and associated APIs you manufacture, sell, and ship to customers in the U.S.
2. Please provide a comprehensive list of retailers in the U.S. that you supply (including any retailers supplied by your customers).
3. Please describe your business relationship(s) with U.S.-based compounding companies and other U.S.-based customers.
4. Please describe your company’s practices used for labeling semaglutide and tirzepatide products and associated API that are imported into the U.S.
   1. Have you ever labeled any of your semaglutide and tirzepatide products “for research use only,” “not for human use,” “animal-grade,” or any other sort of similar labels that might indicate the product is not intended for human consumption?
   2. If yes, how many instances are you aware of such labeling?
   3. Please provide a full list of orders from the past 12 months that contain semaglutide or tirzepatide products and/or associated APIs that were labeled with any of the aforementioned labels.
5. Please describe any agreements made with U.S.-based compounding companies regarding labeling of semaglutide and tirzepatide shipped into the U.S.
6. Please describe the manufacturer safety assurance procedures your company uses to monitor any and all facilities where semaglutide and tirzepatide and associated APIs are manufactured.
7. Please describe the safety and quality testing procedures your company uses for all manufactured semaglutide and tirzepatide products and associated APIs.
8. Please produce your company’s drug manufacturing license in the PRC.
9. Please produce your company’s registration, if applicable, with the U.S. FDA.
   1. In the preceding 36 months, how many times has the U.S. FDA inspected your facilities?
   2. Please provide any U.S. FDA-issued Form 483s or U.S. FDA warning letters your company has received.
10. Please describe any subsidies, funding, or other benefits your company receives from any government entity in the PRC.

This request serves as an ongoing reminder for companies to be vigilant with compliance and safety measures for purchased GLP-1 product API. Companies should conduct rigorous due diligence, including verifying that suppliers are registered with the FDA and listed on the agency's Green List, in addition to reviewing product labeling and certificates of analysis and always maintaining detailed purchasing records.