FDA Releases Guidance on Identification of Suspect Product and Notification
As those following all of the excitement surrounding the Drug Supply Chain Security Act know, the FDA was required to provide the industry with guidance on suspect product and notification no later than 180-days after the DSCSA's enactment. (21 U.S.C. § 360eee-1(h)(2)). The DSCSA was enacted on November 27, 2013, so the FDA missed the deadline by a mile when it released this guidance on December 8th, but at least we have it. You can find the guidance here.
To refresh your memory, the DSCSA requires trading partners that identify suspect product to quarantine the product while further investigating. If the trading partner determines the product is illegitimate (counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or otherwise unfit for distribution), within 24 hours the partner must notify the FDA and all immediate trading partners that might have received the product. The guidance notes that third party logistics providers are not included in the definition of "trading partner" and therefore are not subject to these recommendations, though the FDA encourages them to follow them if the situation arises.
The DSCSA requires this particular guidance document to provide specific scenarios that could increase the risk of a suspect product entering the supply chain. The FDA dutifully identifies the following areas where trading partners should be especially diligent: purchasing from new sources; purchasing in response to an unsolicited offer from an unknown source; purchasing on the Internet from an unknown source; and, purchasing from a source that in the past has been engaged in questionable activity. Transactions that have an increased risk involve products that are in high demand, are at a price "too good to be true", are subject to a shortage, have a questionable appearance, or have been previously been counterfeited or diverted, among other flags. All in all, a fairly common-sense list.
To assist in "expeditiously" identifying suspect product and conducting an investigation, the FDA recommends trading partners discuss with each other observations, questions, or concerns regarding a suspect product and contacting regulatory authorities and law enforcement to aid in that determination.
Once a trading partner makes a determination that a product is illegitimate, the FDA provides a process for notifying the FDA of the determination. Not surprisingly, the process involves filling out a form from the FDA's webpage. Manufacturers will follow a similar process, and all should notify immediate trading partners of the issue. The guidance also describes a process for terminating the notification, which involves accessing that same form, and describing the product, the notification that was issued, and an explanation about the actions that have taken place or what information has become available that makes the notification no longer necessary. It is important to note that because the DSCSA requires the FDA to provide guidance on how to terminate a notification, the FDA considers the process for terminations described in the guidance to be binding.
Because the DSCSA requires trading partners to make a determination that notification is no longer necessary "in consultation with the Secretary", the FDA intends to pay a role in that process by requiring trading partners to "provide the Agency with an opportunity to provide its expert views and advice[.]" See Section IV.B. A trading partner must wait until the FDA responds to the termination request before notifying other partners of the termination - a response the FDA promises within 10 business days. Once the FDA provides its undoubtedly speedy response, the trading partners can then notify their own trading partners of the termination.
Finally, the FDA provides some additional language "for comment purposes only" regarding its interpretation of the DSCSA's requirement for manufacturers to notify the FDA and immediate training partners of products with a high risk for illegitimacy. In these circumstances, manufacturer must notify the FDA within 24 hours of determining or being notified by the FDA or a trading partner that there is a high risk an illegitimate product is in or about to enter the supply chain.
In terms of the recommendations in this document, the FDA has compiled a list of common sense guidelines for identifying suspect product that trading partners are likely already using today. The various processes are fairly straight-forward, but it will be interesting to see how well the FDA keeps to that 10-day response timeline for terminations. Considering how long it took this guidance to come out, it may struggle a bit with that deadline.
For questions, contact Susan Trujillo at (602) 229-5318/susan.trujillo@quarles.com or your Quarles & Brady attorney.