September 5, 2013 | Posted By Bruce D. White, DO, JD

At a conference a few days ago I sat beside a former deputy commissioner of the Food and Drug Administration (FDA). We were in a small group that was discussing the need to help interested parties in Brazil, China, and India learn more about US drug regulatory affairs and compendial science. As best I could understand, the food and drug regulatory infrastructure in China and India appears to be much the same as it was in the US around the 1930s and 1940s. However, everyone agreed that China and India have some of the best medicinal chemists, pharmaceutical formulations engineers, and pharmacy plant manufacturing and pharmacokinetics specialists in the world.

During the conversation I learned that the vast majority of the world’s commercially available antibiotic products are manufactured in China and India. This information struck me as a shock! Until then, I had been under the impression that when the last antibiotic manufacturing plant closed in the US in 2004 and the industry moved off-shore, that the companies had gone to Puerto Rico and Europe. But China and India?

Only recently China has been in the national headlines with stories about their drug and food supply problems. Recall the contaminated infant formula problem that was reported in China in 2006? It was not in the distant past – 2008 – that it was discovered that China was the source of a contaminated heparin product (a blood thinner), which resulted in a number of deaths. In that case, it appears that one supplier was delivering a counterfeit drug rather than the active ingredient to the manufacturer. Only this year, there have been reports that international pharmaceutical manufacturers have been implicated in a several corruptions scandals in Hong Kong and other parts of China. And unfortunately, this followed shortly after these same pharmaceutical companies invested multiple billions of dollars in new drug development and research in China. 

As shocking as the news about the fact that the world’s antibiotics are supplied by China and India, even more alarming was the number of FDA inspectors in China: four. In all of China: four FDA inspectors. And, then today’s New York Times article by Stephanie Clifford and Steven Greenhouse entitled “Fast and Flawed Factory Inspections Abroad”!

During the conversation, the former FDA deputy commissioner – in commenting about the food and drug regulatory infrastructure in evolving markets and the integrity of the world’s drug supply chains – said it kept him up at nights sometimes worrying about it. With all these recent reports, it’s easy to see why.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.