Even with more funding, FDA Commissioner Andrew von Eschenbach acknowledges that FDA can never inspect every production facility
around the world. He looks to strengthen ties with foreign regulatory authorities to enhance FDA's ability to respond quickly
to safety problems. When FDA inspectors sought to examine Chinese upstream pig processors that make crude heparin, it helped
that US and Chinese health officials had signed a memorandum of agreement (MOA) last December supporting regulatory cooperation.
FDA hopes to establish regulatory offices in China and in other regions of the world as part of the "FDA Beyond our Borders"
initiative to boost US regulatory presence overseas.
At the same time, FDA had to tread lightly with Chinese officials anxious to save face. Last year, the Chinese government
executed the former head of the State Food and Drug Administration (SFDA) for fraud in approving unsafe drugs, and Chinese
regulators bristled at speculation that widespread pig disease may have contaminated China's heparin supply chain. SFDA officials
insisted that they strictly regulate chemicals used in pharmaceutical products and emphasized that importing countries and
companies are responsible for ensuring product safety and quality.
US regulators agree that government agencies are not solely responsible for the quality of drug products, whether imported
or not. Although FDA inspects API manufacturers, the agency still relies on industry product testing, and most foreign regulators
leave API monitoring entirely to manufacturers.
At a February conference on FDA enforcement sponsored by the Food and Drug Law Institute, David Elder, director of FDA's Office
of Enforcement, emphasized that the manufacturer of the finished product has to take responsibility for problems with drug
quality or safety. Too often, he said, manufacturers want to blame suppliers for product failures. He pointed to pharmaceutical
companies in asserting that FDA "will continue to hold them accountable" for such problems.
Under the Food, Drug and Cosmetic Act, the marketer of a finished drug product is ultimately responsible for quality and safety,
even if a contractor is at fault, explained Eric Blumberg, FDA deputy chief counsel for litigation. Peter Arduini, president
of Baxter's Medication Delivery business, acknowledged that Baxter takes "this responsibility to produce quality products
An earlier FDA inspection of Changzhou probably would not have prevented all these problems, whether the contamination was
intentional or just an error. Baxter had been using heparin API from China for several years without any serious reactions.
But the crisis illustrates the risks as well as benefits of international sourcing—and the challenge for FDA in retaining
its "gold standard" regulatory status.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com