A requirement for country-of-origin labeling for pharmaceutical ingredients was placed once again on the Congressional agenda, with the introduction of a Senate bill (S. 3633), the Transparency in Drug Labeling Act, which was introduced by Sen. Sherrod Brown (D-OH) in late September. The bill is another effort by Congress this year to mandate country-of-origin labeling for pharmaceutical ingredients, which is increasing the likelihood that the pharmaceutical industry may see such a requirement in the future.
Country-of-origin labeling for active pharmaceutical ingredients (APIs) had also been proposed in the initial discussion draft of the Food and Drug Administration Globalization Act, which was issued in April 2008. The new proposal by Sen. Brown, however, would require country-of-origin labeling not only for APIs, but also for inactive ingredients and would apply to prescription and over-the-counter drug products.
Congressional and public interest in increasing the transparency of the pharmaceutical supply chain is strong, following this year’s high-profile incident of contaminated heparin and other incidents involving adulteration of nonpharmaceutical products such as tainted milk in China. These incidents are contributing to an overall push to enhance the visibility of product supply chains, including pharmaceuticals.
After a multiyear effort, the US last month put into effect interim regulations requiring country-of-origin labeling for food commodities, offering another signal of what may come for the pharmaceutical industry.
Legislative and/or regulatory efforts to increase the transparency of the pharmaceutical supply chain is a good thing, but country-of-origin labeling for pharmaceutical ingredients is a more complex proposition than for food products, something that needs to be taken into consideration when assessing the effectiveness of any such measure.
The country of origin for an API is not restricted to a single manufacturing location. For example, raw materials, intermediates or select steps of a multistep synthesis may be sourced from or outsourced to various productions sites offshore, with the final steps of an API synthesis performed captively by a pharmaceutical manufacturer located in the US or Western Europe. To add true effectiveness to any measure, all points in the supply chain need to considered, but such an approach would seemingly add unwanted complexity in any reporting requirement.
Where country-of-origin labeling may have “teeth” is for APIs for generic drugs and OTC products, which by the very nature of these markets, are commoditized products, making them likely candidates for production in lower-cost countries, where the entire API is manufactured offshore. The drugs in these cost-competitive markets have little product differentiation, and country-of-origin labeling may even serve to offer pharmaceutical manufacturers an opportunity for differentiation.
It is unlikely that any measure for country-of-origin labeling will move forward in 2008, given the changing political landscape in an election year and the current legislative and executive priorities centering on the financial/economic crisis. The question for 2009 is whether country-of-origin labeling and other proposals and actions to ensure the integrity of the pharmaceutical supply chain will be on the political agenda or fade with the ascent of other issues now in the making.