FDA plans to withdraw some pedigree elements of PDMA

The US Food and Drug Administration has said it plans to withdraw a rule - finalised in 1999's Prescription Drug Marketing Act - which requires all unauthorised distributors of prescription drugs to include a pedigree of all prior transactions back to the manufacturer.

The proposal effectively removes the legal requirement that the pedigree identify each transaction back to the manufacturer including the proprietary and established name, dosage, lot, name and address of parties to each transaction, etc, although this is still encouraged by the FDA.

The pedigree requirement in rule 21 CFR 203.50(a) never came fully into force because industry objections caused a series of 'stays' by the FDA, and has become increasingly problematic given the advancement of state-level initiatives, such as California's e-pedigree legislation, and ongoing debate about the type of track-and-trace system that should be rolled out at the federal level.

"There have been serious ongoing concerns about the effect that full implementation of the statutory pedigree requirements, as codified in 203.50(a), would have on the nation’s drug supply and on wholesale distributors," says the Federal Register notice highlighting the proposal.

One of the consequences of the PDMA was to introduce two tiers of medicine distributors in the USA: authorised (in other words the 'official' distributor of a pharmaceutical manufacturer) and unauthorised (a wholesaler or distributor who purchases medicines from authorised wholesalers).

The unauthorised sector is now commonly referred to as the secondary wholesale market, and is estimated to account for around 5 to 10 per cent of the total US wholesale market, with 90 to 95 per cent taken by the big three wholesalers - McKesson Corp, Cardinal Health and AmeriSourceBergen.

In 2006, secondary wholesaler RxUSA Worldwide secured an injunction against the implementation of 203.50(a), successfully arguing that unauthorised distributors could not meet pedigree requirements because authorised distributors were neither required nor willing to provide information back to the manufacturer, leaving a gap in the pedigree. This position was subsequently upheld by an appeals court.

The FDA says it will exercise enforcement discretion with regard to the 203.50(a) requirements while it is in the process of being repealed, provided the pedigree identifies "the last authorised distributor of record that handled the drugs and the associated dates of the transactions."

"FDA plans to withdraw the subsection of the regulation in order to mitigate confusion and clarify pedigree requirements," said an FDA spokesperson.

"FDA’s proposal to withdraw the subsection does not change the statutory requirement under the FDCA for all distributors who are not authorised distributors of record to provide a statement that identifies each prior sale, purchase, or trade of a drug, including the date of the transaction and the names and addresses of all parties to the transaction," she stressed.