A federal court judge has imposed a temporary injunction against the FDA over the agency's drug pedigree requirements, on the basis that the regulations leave sections of the supply chain unguarded and threaten the survival of smaller drug distributors.
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The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.
Here’s a link to the complete story:
The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.
