In our earlier blog about the growth of Contract Manufacturing Organizations (CMOs), you read about the challenges facing regulators due to a radically altered supply-chain, and particular challenges in the management of quality. One story highlights these challenges — the story of contaminated Heparin.
Heparin is one of the oldest drugs in widespread clinical use and is used principally in medicine for anticoagulation (blood thinning). In 2008, contaminated Heparin led to the deaths of over 80 patients and to hundreds of allergic reactions in the U.S. Contaminated batches were found in 10 other countries. The contamination was traced by the FDA to contract manufacturers and materials suppliers in China (over a dozen companies were identified).
As a result, the U.S. House of Representatives Government Accountability Office conducted a review and found that the FDA’s budget was less than one sixth of that required to inspect foreign drug ingredient makers every two years. In response, the FDA announced plans to hire 1,300 new staff that year and has since stepped up its pressure on quality assurance in the supply chain. In 2009, 12% of 483 observations and 16% of warning letters issued were related to inadequate supplier qualification.
Whether the motive is to help reduce costs or to add capacity, tier one producers are rapidly reconfiguring their supply chains and pushing more of their manufacturing production back up the supply chain. The Heparin incident proves that the industry needs to find an appropriate balance between outsourcing to reduce costs and improve flexibility, and maintaining product quality.