Heparin Scare Tests FDA’s Drug Quality Agreement With China

The FDA’s memorandum of agreement (MOA) with Chinese regulators was put to the test during its investigation into adulterated batches of Chinese-made active pharmaceutical ingredient (API).

The API was used in Baxter’s recalled heparin products and has caused concerns about the world’s supply of the drug, which is an injectable blood-thinner used for patients undergoing hemodialysis and certain types of cardiovascular surgery.

“Heparin has become kind of an example of how the MOA actually works in a real live situation,” Murray Lumpkin, the FDA’s deputy commissioner for international affairs and special programs, said during a recent conference call.

Chinese regulators were cooperative, shared information and expedited the process for FDA inspectors to obtain visas, Lumpkin said. “We have also had ongoing discussions with our Chinese colleagues as the investigation has progressed. This is the kind of relationship that did not exist during the time of melamine [in pet food] about a year ago,” he added.

Under the agreement signed late last year, the FDA has access to inspection information from Chinese regulators and lists of manufacturers that do not meet Chinese standards. China’s State Food and Drug Administration also will work to create a system that allows it to certify that firms and their products meet FDA requirements.

Pfizer’s cholesterol drug Lipitor (atorvastatin calcium) and erectile dysfunction drug Viagra (sildenafil citrate), human growth hormone, Roche’s influenza medication Tamiflu (oseltamivir phosphate) and antibiotics cephalosporins and gentamicin sulfate are all covered under the MOA. Heparin is not.

However, based on how the MOA worked during the investigation, Lumpkin said it did not matter which drugs are covered under the agreement.