Why was Baxter International, Inc.’s Heparin recalled and APP Pharmaceuticals Heparin unaffected by the recent outbreak of allergic reactions and deaths? The answer is simple yet complex. Clearly, Baxter secured its product through a chain of distribution which, along the way from the slaughtered pig to the extraction and packaging of the raw agent, became adulterated. What may be ultimately discovered, however, is that the distribution chains utilized by Baxter and APP were both complex and susceptible to error but that Baxter failed to perform any testing and quality control on its product as it was entering the United States. The FDA has reported that Baxter’s representations as to its distribution chain in the aftermath of the outbreak and recall were not accurate. So, not only was there a failure at the point of entry into the U.S., but Baxter’s own understanding and grasp of its vendor supply chain was murky to say the least.
The FDA did apparently visit some of APP’s distributors in China but failed to inspect countless Baxter sites. However, it is not the FDA’s role or obligation to protect consumers. Rather, once it approves a product (based on the manufacturer applicant’s own representations), the drug maker is wholly responsible for pre-sale inspection and testing and post-marketing surveillance.
Baxter’s failings here are too many to count and, fortunately for consumers who have been harmed, it will not be able to hide behind the recently expanded and bastardized legal tenant of “preemption”.