The US Food and Drug Administration needs to adopt a new approach to protecting the US drug supply, as its current system is not safe from counterfeiters, according to the National Coalition of Pharmaceutical Distributors (NCPD), which represents small and independent pharmaceutical distributors.

The group has welcomed the temporary injunction imposed in December against the FDA’s current measures, following a court challenge brought against the FDA’s “pedigree” method of preventing counterfeit drugs from entering the supply chain.

The 1988 Prescription Drug Marketing Act defines a “pedigree” as a

record that identifies where a product came from and who is selling it. It also defines an “authorised distributor” as someone who receives pharmaceutical products directly from the manufacturer. The FDA regulations, as they stand, would exempt an AD from providing a pedigree to its customers, regardless of where it obtained the product.

Distributors who do not obtain their products directly from the

manufacturer would be obliged to provide pedigrees. However, these

pedigrees can come only from manufacturers, or the AD themselves. ADs had said they would provide the necessary documentation but some have refused to do so, or they have imposed extraordinary additional costs and decreased service levels for providing them, said the plaintiffs.

Imposing the injunction, Judge Joanna Seybert noted that, while “the

pedigree requirement was created to show where wholesale distributors were obtaining their drugs,” the AD exemption “would essentially wipe out all the unauthorised distributors, leaving only [ADs] who are exempt from the pedigree requirement. So none of the drugs ultimately going to the American consumer would contain pedigree information because the drugs would be provided solely through [ADs] who are exempt from the requirement.”

“This rule may drastically change how prescription drugs are

distributed in this country, and ultimately affect the cost to the

consumer,” Judge Seybert warned.

The NCPD welcomed her opinion, and pointed out that the FDA had

essentially come to the same conclusions as far back as 2001, yet it

opted to re-impose the pedigree rules with the same gaps and

shortcomings earlier this year.