Janet Woodcock, director of the Center for Drug Evaluation and Research for the US Food and Drug Administration, spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) annual dinner earlier this month, emphasizing the need of regulators and industry to meet the challenge of securing an increasingly complex global pharmaceutical supply chain. Her words were very well taken and show the recognition not only by FDA and other regulatory authorities, but also of pharmaceutical manufacturers and their suppliers, that the elongation of the global supply chain brings with it new responsibilities and ways of doing business.

When it comes to globalization, it is clear that the genie can’t be put back into the bottle, so the issue becomes how to effectively regulate the activities of players of all size and resources under a uniform and enforceable system. This understanding leads to a fundamental question: Should regulation without borders be a paradigm that we strive for to deal with globalization?

To answer this question for the pharmaceutical industry, perhaps we should look at other markets, most notably the financial/banking sectors, which obviously have come under acute stress from recent events. UK Prime Minister Gordon Brown and France’s President Nicholas Sarkozy were among the leaders last fall that urged for the establishment of a new global system of financial governance and regulation. Proposals under consideration included a global early-warning system, globally accepted standards of supervision and regulation, cross-border supervision, and cooperation and concerted action in a time of crisis.

If such a framework were in place in the pharmaceutical industry, would we have had contaminated heparin from China, manufacturing violations from Ranbaxy, India’s largest generic-drug manufacturer, which resulted in a subsequent import alert imposed by FDA on 30 generic drug products? Perhaps, yes, as these examples may be regarded as individualized cases that were eventually uncovered by an existing framework of national regulatory enforcement.

But perhaps more importantly are not the cases that are uncovered, but the uncertainty of what remains unknown and that falls into the cracks of a still largely fragmented global regulatory framework for pharmaceutical regulation.

The activities of the International Conference on Harmonization, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization, and cooperation between national and regional regulatory authorities such as FDA and European Medicines Agency are all positive developments, but are they truly adequate for managing the global pharmaceutical supply chain?

Although agreement may be reached on what global manufacturing standards should be, the real task resides in achieving even and sufficient enforcement, a problem not effectively resolved strictly at the border.