Industry Is Worried Guidance on Counterfeits May Make More Pharmaceutical Shortages

Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended.

The guidance, released earlier this year for comment, includes scenarios and recommendations to help trading partners such as manufacturers, pharmacies, repackagers and distributors identify counterfeit or suspect products.

For example, the guidance calls on trading partners to watch out for products that are expensive, in limited supply, are labeled in a foreign language, have a broken seal or are missing watermarks.
The problem, say industry groups, is that these characteristics taken together might suggest a product is suspicious, but a product with only one of these characteristics shouldn’t be viewed as suspect.

For example, FDA regulations allow labeling in a foreign language if the product is distributed in a territory such as Puerto Rico where English isn’t the predominant language.

Moreover, not all products use holograms or watermarks, so a lack of these markers isn’t necessarily cause for suspicion, says the Biotechnology Industry Organization.

PhRMA warns that if trading partners raise an alarm each time a product has one of the FDA’s characteristics of a counterfeit, the agency’s reporting system will be overburdened with false alarms, which “may result in failure to properly identify product that is actually suspect or impact product availability by leading to unnecessary quarantining of product.”

The agency should clarify that the characteristics are risk factors that should be considered as part of a broader risk assessment, BIO adds.

Industry groups also had qualms about the FDA’s process for quarantining a suspect product. Under the draft guidance, companies can submit a Form 3911 to the FDA requesting that quarantine be lifted on a product wrongly suspected of being illegitimate.

The agency intends to respond to requests for termination of quarantine within 10 business days, but may use additional time if needed, the guidance says. During that time, the product remains under quarantine.

While quarantining a suspected product is important, a long delay could lead to shortages, says the Pharmaceutical Distribution Security Alliance, a coalition of manufacturers, distributors, repackagers, third-party logistic providers and pharmacies.

The FDA should amend the guidance to respond to requests for termination within three business days rather than 10, says Novo Nordisk, one of 19 stakeholders to submit comments on the draft.

PDSA also pressed for a three-day turnaround on termination of illegitimate product notification requests and urged the agency to retain a provision for expedited review and establish a clear process for making such a request.

The guidance on counterfeits was mandated in the 2013 Drug Quality and Security Act, which created a nationwide track-and-trace system for pharmaceuticals.

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