Although the cause of product contamination was not readily apparent, the fact that the active pharmaceutical ingredient (API) came from a Chinese facility captured national attention. With unsafe Chinese food, toothpaste, and drugs making headlines, itnot surprising that the media focused on Baxter's Chinese API producer and had a field day running stories on small Chinese operators that obtain an extract from pig's intestines for processing into crude heparin. In fact, the problem has become global. Soon after Baxter reported increased adverse events, a similar situation emerged in Germany.
Compounding the problem in the US was the surprising discovery that the US Food and Drug Administration never inspected the manufacturer, Changzhou Scientific Protein Laboratories, nor did Chinese regulators. This debacle highlighted inadequacies in FDAtracking of drug production at home and abroad. FDA officials admit that their system is so obsolete that they have only a vague idea of what drugs are manufactured where and which overseas facilities have been inspected. The case also focused attention on the limits of FDA's preapproval inspection program. And it emphasized the reality that manufacturers bear the ultimate responsibility for ensuring the quality of all ingredients in a drug product.More imports
The enormous expansion in drug substance imports in recent years has stressed FDA's oversight capacity considerably. At a contentious hearing in Feb. 2008 before the House Appropriations subcommittee that approves FDA funding, Janet Woodcock, then acting director of the Center for Drug Evaluation and Research (CDER), reported that about 80% of APIs come from foreign manufacturers. Committee Chair Rosa DeLauro (D-CT) termed FDA's heparin inspection error as one more example of "FDA's myriad failures" in dealing with multiple drug-safety issues.
Woodcock predicted similar problems in the future with drug products. Although imports of finished drugs now are much lower than those of APIs, she said that this situation "is going to change" because operators in "many regions of the world have indicated that they want to take over drug manufacturing."
This trend will demand further changes in FDA's current good manufacturing practice (CGMP) compliance activities. The agency has been inspecting only about 10% of foreign drug producers each year because field-inspection operations are inadequately funded, Woodcock explained. And because FDA faces deadlines for conducting preapproval inspections (PAIs) of suppliers and producers of new drugs, many low-priority facilities seldom see an FDA agent.