China’s quality control standards, like its environmental regulations, have a long way to go before they protect consumers inside or outside of the country. As China compresses into decades what took the U.S. and Europe nearly a century to accomplish, the environment is much like the “frontier” that existed in the U.S. in the 1950s, before FDA’s powers were extended or the EPA was established.
Recent news has focused attention on quality issues at more Chinese API manufacturing plants, only a fraction of which have been inspected by FDA.
As the Agency considers having more agents based on the ground in China to conduct surprise inspections of facilities, recent quality issues with batches of Baxter’s generic heparin have only intensified the “China Syndrome,” and U.S. outcry against Chinese drug manufacturers. They’ve also increased criticism of FDA.
Last week, the Wall Street Journal reported that a joint-venture supplier based in China had made the active ingredient that Baxter used to manufacture recalled batches of heparin, which reportedly led to adverse patient reactions. Later, it became clear that the facility had never been inspected by FDA, due to a clerical error.
Heparin, a critical and widely used injectable drug, brings the issue of safety a whole lot closer to the individual consumer than the pet food or even the toy scandals did.
Both the media and the public blame FDA and China, while many in the U.S. broadly complain that the U.S. government has allowed Chinese imports of all kinds to flood the markets, unchecked. As more U.S. jobs, including pharma industry positions, move to China, it’s easier than ever to blame the nation’s quality standards.
But let’s stop blaming Chinese manufacturers for quality problems. After all, they are only following the age-old law followed by industries and businesses everywhere for centuries: get away with whatever you can if it reduces cost. Why were FDA and EPA set up in the first place?
Let the nation whose manufacturers don’t ever follow this rule cast the first stone.
Perhaps we should also stop blaming FDA, which is struggling with funding, staffing and other issues at a time when it is being called upon to police the world’s food and drug supply.
Instead, let’s place the blame where it belongs: with sourcing companies, whatever industry or part of the world they’re based in, that fail to establish robust, reproducible quality standards for themselves and their suppliers and fail to enforce them consistently.
In an industry already struggling with the variability of its raw materials and its APIs, and still unable to link that variability to clinical effects in patients, could specs have been just lax enough to allow defective materials through?
Which brings up some interesting questions: what do you really know about your suppliers, and, more importantly, their suppliers along the chain? Do you extend the same stringent requirements for them that you follow within your own facilities?
Do you choose to do business only with FDA-, EMEA- and Japanese-inspected and approved companies? Have you or your colleagues personally checked those facilities, with experts fluent in the local language and customs, and vetted the companies thoroughly?
Do you know where your contractors are sourcing all their raw materials and services?
Are you availing yourselves of the best technologies and methodologies for assessing risk, be they rapid microbial detection methods, process analytical technologies, or environmental monitoring systems?
Due diligence is critical to any contract manufacturing agreement. It’s also extremely difficult. But consider the consequences of failure. The buck stops, not with the Chinese, but with you.
Editor's Note: What are your thoughts on this issue? Please send your comments to [email protected].
