Supply Chain Matters has had multiple posts since February regarding the incident of contaminated supplies of the drug Heparin being shipped to the U.S. from China. In insuring due diligence, we highlight in this post the latest update from the U.S. Food and Drug Administration (FDA) as reported today in an AP story.
“We have put in place processes that we believe can ensure the safety of the heparin supply within the United States” declared U.S. Health and Human Services secretary Mike Leavitt in an interview on Monday in Shanghai. ‘What you will see from the United States is a substantial change in our strategy” noting plans to station FDA inspectors in China and other countries. Mr. Leavitt however further cautioned “we believe the system that we have for ensuring safety is a good one but completely inadequate for the future”.
As commented in our Drug Imports from China- Controls Are Mandatory, as well as Drug Imports From China- a Wider Problem posts, this again reiterates that regulatory agencies are ill equipped to keep-up with the pace of current outsourcing of the pharmaceutical and drug supply chain, and risk mitigation must stem from internal and external controls built within such supply chains. Sourcing materials solely for pure cost savings, is penny wise and pound foolish in the drug manufacturing value chain. The sourcing or procurement group, nor the U.S. FDA do not hold the sole bag for product quality, the complete value-chain, and all groups involved, collectively need to own that responsibility.