A recent Wall Street Journal blog post, “The Problem with Drug Provenance,” broached an interesting debate on whether the origin of ingredients in a drug should be listed as part of the drug’s product information.
The public and industry discourse on monitoring the safety of pharmaceutical ingredients is high following the case of contaminated heparin from China (see ePT story, “FDA Clarifies its Role in Heparin Investigation”). The heparin incident was the latest in a series of developments in which the US Food and Drug Administration’s ability and resources to effectively enforce good manufacturing practices from foreign drug-manufacturing facilities has been put into question.
Industry groups such as the Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group, which represent batch, custom, and fine chemical manufacturers, have been vocal critics over what they say is uneven and infrequent inspections by US and European regulatory authorities of foreign producers of pharmaceutical ingredients (see ePT story, “EFCG and SOCMA Urge More Inspections of Foreign API Makers”).
More funding to increase the number and frequency of foreign inspections is an obvious solution, but a difficult one given continual budgetary limitations of FDA and European national regulatory agencies.
Instead, would greater transparency in the pharmaceutical supply chain be the answer? As with any consumer product, the country of origin in which the product is manufactured is identified. Should the same practice be followed with active pharmaceutical ingredients (APIs)?
More than 80% of the APIs that go into drugs come from abroad, and India and China account for almost half of those imports, according to testimony from Rep. Bart Stupak (D-MI), chairman of the House Subcommittee on Oversight and Investigations, who spoke on the issue last November. He said that India’s pharmaceutical imports into the US increased 2400% from 1996 to 2006, making it the fastest-growing drug importer, and China has doubled its pharmaceutical exports to the US over the last five years (see ePT story, “Congress Focuses on FDA Inspections of Foreign Drug Facilities”).
There is no substitute for inspecting drug-manufacturing facilities, but until regulatory practices can be aligned with manufacturing activity, let consumers decide if the origin of APIs affects their purchasing decisions. Public disclosure may be the greatest equalizer in this debate and obligate pharmaceutical companies to reevaluate their supply chain.