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    FDA Needs to Get Out More:More Foreign API Plant Inspections Needed, But Where’s the Funding?

    June 18, 2007
    Recently, the Synthetic Organic Chemicals Manufacturers Association (SOCMA) argued that FDA must step up inspections of plants outside the U.S., particularly in China, that manufacture active pharmaceutical ingredients (APIs).  The volume of APIs imported into the U.S. has more than trebled over the past few years, while the overall number of new inspectors the Agency has hired is up by only 10%. At a time when over 80% of the APIs sold in the U.S. are imported (half of them from China and India), is this situation tenable? However, at the same time, Congress Daily noted that FDA budgets are "stretched thin." The Agency has responded pragmatically to funding constraints, by focusing on those manufacturing plants that would pose the greatest risk.   This may be the best FDA can do, under the circumstances, but dangerous materials are slipping through the cracks. The China-based "melamine in the pet food" story may have shown us just the tip of the iceberg.  Seven years ago, FDA was able to inspect 249 foreign API manufacturers, but by 2004, that figure had slipped to 163.  Although the jury is still out, there may not be all that much to worry about from Chinese API manufacturers whose ingredients are used in precription medicines, but over-the-counter prescriptions, personal care products and nutraceuticals using untested imported APIs still pose risks to consumers. Chemical and Engineering News posted a nice overview article on this issue today.  It would seem that the ultimate solution would be more funding and staffing for FDA, which is hard pressed keeping up with food safety, pharmacovigilance, and increasing the level of scientific knowledge within the Agency required for Critical Path and Quality by Design--- as well as preventing defections of loyal, talented staff.  Food and pharmaceutical duties could also be separated. Perhaps the Agency will have to set up satellite branches in India and China over the next few decades, as offshoring to those countries increases, and maybe programs like USP's ingredient verification programs offer an answer (but how many small API manufacturers abroad would pay for certification). Can this situation be turned around, and how?  -AMS
    Recently, the Synthetic Organic Chemicals Manufacturers Association (SOCMA) argued that FDA must step up inspections of plants outside the U.S., particularly in China, that manufacture active pharmaceutical ingredients (APIs).  The volume of APIs imported into the U.S. has more than trebled over the past few years, while the overall number of new inspectors the Agency has hired is up by only 10%. At a time when over 80% of the APIs sold in the U.S. are imported (half of them from China and India), is this situation tenable? However, at the same time, Congress Daily noted that FDA budgets are "stretched thin." The Agency has responded pragmatically to funding constraints, by focusing on those manufacturing plants that would pose the greatest risk.   This may be the best FDA can do, under the circumstances, but dangerous materials are slipping through the cracks. The China-based "melamine in the pet food" story may have shown us just the tip of the iceberg.  Seven years ago, FDA was able to inspect 249 foreign API manufacturers, but by 2004, that figure had slipped to 163.  Although the jury is still out, there may not be all that much to worry about from Chinese API manufacturers whose ingredients are used in precription medicines, but over-the-counter prescriptions, personal care products and nutraceuticals using untested imported APIs still pose risks to consumers. Chemical and Engineering News posted a nice overview article on this issue today.  It would seem that the ultimate solution would be more funding and staffing for FDA, which is hard pressed keeping up with food safety, pharmacovigilance, and increasing the level of scientific knowledge within the Agency required for Critical Path and Quality by Design--- as well as preventing defections of loyal, talented staff.  Food and pharmaceutical duties could also be separated. Perhaps the Agency will have to set up satellite branches in India and China over the next few decades, as offshoring to those countries increases, and maybe programs like USP's ingredient verification programs offer an answer (but how many small API manufacturers abroad would pay for certification). Can this situation be turned around, and how?  -AMS
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