ePedigree

On April 22nd, 1988, the United States Executive signed into law the Prescription Drugs Marketing Act, following the receipt by the act of Congressional assent. The intent behind the legislation was to prevent the introduction of "counterfeit, adulterated, misbranded, subpotent, or expired drugs" into the American drug supply chain, and the subsequent prospect of imperiling the health and well-being of American drug consumers and patients.

The Act recognized that multiple parallel markets had developed alongside the mainstream US pharmaceutical distribution network that interfered with regulatory oversight over, and sometimes even basic information sourcing about, drugs in retail networks.

The passage of time has seen the scope of these concerns magnified multifold as a result of wholesale transformations of the trade in pharmaceuticals. The practice of secondary trading has disrupted the structure of supply chains, which are no longer generally linear: with delivery routes running unencumbered from manufacturers through various subsidiary consignees to retailers, and thence to consumers. Instead sometimes consignments sold by one wholesaler to a secondary distributor finds its way upward the supply chain to other wholesalers before re-embarking on the downward slope towards the consumer. The effect is that pallets are unpacked, rearranged, reassigned, and repacked several times during the course of a typical trade cycle, rendering implausible any neat conception of stock flow from the manufacturer to the end-user. The FDA estimates that $10 billion of pharmaceutical stock go through these winding routes every year, leading to what the organization describes as "description gaps".

Efforts to find a common ground between the FDA and various interests within the US National Wholesale Druggists Association have alternated between high points of sustained convergence of opinion and low points of disagreement over basic principles.

On 14th March 1994 the FDA published a whitepaper setting out mechanisms for the implementation of the various requirements of the PDMA with especial reference to the Pedigree regulation, which firstly sets in statute a distinction between "authorized wholesalers" and "unauthorized wholesalers" and then requires the latter to provide a statement detailing all prior purchases of the pharmaceutical stock to the purchaser. Contentions soon arose as to the meaning of the term, "authorized" as used in the legislation and about the exemption of the so-named authorized wholesalers from the requirement to submit pedigree statements. Careful analysis of the regulation seemed to reveal that exempting a part of the supply chain from the obligation to keep statutory records necessarily impaired dependent parts from complying with the obligation. Many secondary distributors who were most likely to fall under the category of "unauthorized wholesalers" argued that they had no way of supplying a list of prior purchases if those they bought their stock from, if they were authorized wholesalers, did not have to pass information on to them.

Commentators also raised the issue of safeguards against fraud, suggesting that without some means of verifying pedigree statements the system merely imposed additional burden on the industry without addressing any of the problems it set out to solve.

These assorted concerns led to several deferments of the full implementation of Pedigree requirements in the Act (by then amended) after the final regulations were published on December 3rd 1999.

It is predominantly in response to these concerns that an electronic approach to Pedigree documentation was broached as an efficient and comprehensive solution to various bottlenecks. RFID (Radio Frequency Identification Devices) is seen by the FDA as holding the best prospects for the management of electronic Pedigree (ePedigree), though in more recently the Agency has grown increasingly warm to the idea that other technologies either on their own or in tandem with RFID could achieve satisfactory results.

EPedigree implementation has however proved immensely entailing for the industry, and complaints have ranged from the high costs of the technology to its occasional sub-optimality. Legal liability worries have also emerged. Some campaigners believe that an electronic Pedigree system could diffuse legal responsibility for drug safety and efficacy, even though it is not clear why the same is not the case with paper-based Pedigree systems, and if it is in what way liability is distorted in the presence of better information rather than clarified by it.

At any rate, the scheduled enforcement of the FDA’s federal ePedigree initiative on December 1st 2006 was blocked by the US Courts at the instance of secondary and small wholesalers who cited costs and complexity.

Clearly, protecting drug supply chains is a noble but challenging undertaking, even in the most economically and institutionally advanced societies. Does that mean though that it is infeasible?

This discussion draws heavily on the contents of the Prescription Drug Marketing Act Report to Congress, Department of Health and Human Services, U.S. Food and Drug Administration, June 2001.