19 drugmakers made drugs with raw materials lacking drug permits; FDA: operators took shortcuts; New Wan Jen: we apologize

In addition, Lee Ming-hsin mentioned that because food-grade raw materials come from many sources, including food factories or imports from abroad, it is currently impossible to know which suppliers the drugmakers purchased raw materials from.

As for whether using food-grade raw materials as the main ingredients of drugs affects efficacy, Lee Ming-hsin said that according to the raw material and final product inspection records issued by the drugmakers this time, all comply with the Chinese Pharmacopoeia, and food-grade raw materials pose a low risk to human health, but some pharmacists remain skeptical about the efficacy.

Operator "New Wan Jen" apologizes, "Abbott" to discuss further with contract manufacturer "Genovate"

As for what the operators said, New Wan Jen Chemical & Pharmaceutical issued a statement on its official website saying that the raw material used in "Golden Cross Enzyme Gastrointestinal Medicine Granules" is food-grade calcium carbonate imported from Japan and has passed testing under Japanese Pharmacopoeia specifications, but due to an operational oversight that was not detected in time, causing public concern, it expresses deep apologies to the public and will fully cooperate with the FDA in the future to implement source management.

Lee Kun-chin, general manager of Abbott's pharmaceutical business unit, said that "Abbott Similac Panna Plus Film-Coated Tablets" are commissioned to be manufactured by "Genovate Biotechnology," and the calcium carbonate main ingredient used is imported from Germany's Merck and complies with U.S. Food and Drug Administration and European Union standards; however, because "Genovate" has not submitted to the FDA the procedural information for an "import permit for self-use raw materials," discussions are still under way with "Genovate" on the information that should be supplemented, and consumers can return the products with a receipt.

FDA: drugmakers still use self-management, but officials will strengthen inspections

At present, before drugmakers produce drugs, the main ingredient raw materials must be reported to the FDA with an "active pharmaceutical ingredient permit," or if raw materials are imported from abroad, there must be an "import permit for self-use raw materials." However, if manufacturers want to change raw materials during the manufacturing process, they only need to evaluate it themselves and do not need to apply to the FDA to change raw materials, and outsiders question that self-management gives manufacturers an opportunity to exploit loopholes.

The FDA responded that under Article 17 of the Regulations for Registration and Review of Drug Verification, for new drugs manufactured starting in 2010, if the active pharmaceutical ingredient is to be changed, the change of source should be registered with the FDA, but this mechanism does not apply retroactively to drugs produced before 2010, and in the future it will evaluate and consider whether retroactive application is possible.

With many major domestic Western drug manufacturers caught in this inspection, how will the FDA mend the net? Lee Ming-hsin said that in the past, FDA factory inspections prioritized spot checks on drug raw materials with efficacy and high risk, and paid less attention to traditional or low-risk atypical active pharmaceutical ingredients, such as calcium carbonate and magnesium carbonate. In future factory inspections, it will strengthen inspections of "multi-purpose raw materials" that can serve as the main ingredients or excipients of drugs and may be used in both drugs and foods.