FDA scales back counterfeit drug notification forecasts

The FDA is expecting to receive far fewer notifications of illegitimate medicines in the US supply chain than previously thought, according to a Federal Register filing.

Previously, the agency had predicted it would receive around 5,000 notifications a year from drug manufacturers, repackagers, wholesale distributors and dispensers which have confirmed or suspect a shipment is illegal, but the new filing now places that estimate at just 1,000.

The document also contains a number of other clarifications to the Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, which was released in draft form in July 2014.

The revised notification estimate suggests that the reporting burden for supply chain actors complying with the DSCSA rules on counterfeit, falsified, diverted and stolen drugs will be considerably less than previously thought.

The reduction has been made at the request of the Healthcare Distribution Management Association (HDMA), a trade organisation representing wholesale distributors, which said the 5,000 estimate was too high did not reflect the true picture in the US supply chain.

Scaling back the number of estimated annual responses - particularly for wholesalers, the FDA now predicts manufacturers and repackagers will account for 800 notifications (to the FDA and multiple trading partners), wholesalers 160 and dispensers 40.

Comments submitted to the FDA last year by the HDMA noted that "as wholesale distributors report receiving typically two or three alerts a year … 5,000 notifications appears to be overly generous and we similarly believe it unlikely that wholesale distributors would need to file 2,500 illegitimate product reports to the agency in a single year."

Other clarifications to the earlier guidance are outlined, including that while the notification requirements apply mainly to fraudulent products, drugs with quality issues (i.e. which are substandard) are not necessarily exempt.

Notifications may also be made public where there is a need for a health advisory and will be subject to the usual disclosure rules under the Freedom of Information Act, it notes.

The notification requirements are just one element of the Drug Supply Chain Security Act (DSCSA - also known as Title II of the Drug Quality and Security Act or DQSA), which was enacted on November 27, 2013, and came into force on January 1, 2015.

The DSCSA replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines based on unique serialized codes on drug packs.