As we all know, Congressman Dingell has proposed the Food & Drug Administration Globalization Act, an important proposal that would enact some very important, far ranging and much needed changes to the FDA. While the Synthetic Organic Chemical Manufacturers Association (SOCMA) believes that increased oversight is a necessary step in correcting the issues of quality and eliminating counterfeiting in emerging markets, I thought I would discuss what companies should themselves be doing in response to these issues.
Industry needs to help itself on this matter. We have seen what happens when companies come under fire. If we have learned anything from recent events, it is clear that firms sourcing from emerging markets need to do their homework and really learn their suppliers. Relying on the FDA’s inspection process is not enough. It is too easy at this point for the FDA to make mistakes. It performs too few inspections with the overseas inspections themselves leaving room for improvement.
Companies must perform their own inspections and investigations. They must make a concerted effort to treat suppliers like an extension of their own firms, being vigilant on quality control, working to make process improvements, and educating suppliers so they understand exactly for what purpose the product is used. It is the responsibility of companies that the materials you import meet all US laws and regulations. In China, firms have not been regulated as a pharmaceutical company unless they register themselves as such. Otherwise they may register as a chemical company, coming under a completely different regulatory regime. Yet these “chemical companies” may still sell their products for use in pharmaceuticals. This is another example of why it is imperative that companies understand the market and its regulatory structure from which you are sourcing.
Other parts of the industry can help themselves in a different way because of these quality issues. No company wants its name associated with quality issues, whether because of underperformance or adverse effects. The public relations hit on a consumer brand can be enormous, with a corresponding loss in sales. US domestic firms should be trying to capitalize by emphasizing process control, quality review, and innovation. We have seen the rising tide of outsourcing wash through the industry, but it is now slowing and US firms need to respond quickly if they are to regain traction.
Joe Acker is president of the Synthetic Organic Chemical Manufacturers Association (SOCMA).