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Let’s Talk Pharmaceuticals

May 15th, 2010

Long before my not-long-ago post on FDA, a man in Pennsylvania had run across my book and wrote to tell me about research that he was doing in pharmaceuticals. For those who may be involved in pharma and for many of those concerned about the threat posed by lax controls in supply chains, I present the following bedtime story: Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients. Prepared for the U.S. China Economic and Security Review Commission, the report is detailed. From the first paragraph of the executive summary:

Against the backdrop of recent health and safety concerns caused by tainted, or otherwise unsafe raw materials discovered in imported products from China, this report attempts to address similar concerns on the potential array of health risks to American consumers from imports of specific raw materials supplied by China used in the U.S. manufacture of pharmaceutical and supplement products…

When I was in business school, a group of us made a field trip to the McNeil plant that manufactures Tylenol caplets. It was spotless; not a cart, tool or dustpan was out of place. Having visited that facility and then having later inspected hundreds of factories in China, I can assure you that we have far less to worry about at home than we do abroad. But this is not new information.

The report I mention (above) came out a good month or so before FDA’s recent investigation at McNeil, and I can’t be the only one who finds the timeline disturbing. Just when FDA should be highlighting problems with materials from China, it has turned the spotlight on U.S. manufacturers. It shouldn’t be this way. I’m in touch with a growing number of professionals who work in consumer product safety. Some of these people work for large multinationals, others are in government. Most of these folks are interested in increasing quality standards, in general, but there are, unfortunately, political aspects to the problem. I write on quality issues because they interest me, and in order to promote discussion on a subject that I believe is important to all. My hope is that some who might catch this note will choose to discuss this topic openly with others.

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