I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”). I highly recommend that you read those letters. But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance. Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019. To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI).
The letter is not on their website, and in fact, the only way you can find it is as one of the attachments to a letter the PDSA submitted to an FDA Docket last November 14. Here is the link to that letter on the Regulations.gov Docket page: https://www.regulations.gov/contentStreamer?documentId=FDA-2016-N-2673-0007&attachmentNumber=1&contentType=pdf .
Once you open that letter, scroll down to page 15. That should be the first page of the PDSA letter to Dr. Ilisa Bernstein, Deputy Director, Office of Compliance in the FDA, dated November 10, 2016. The subject is “Early Serialization under DSCSA”. They are concerned that:
“…it may be difficult, or even impossible, for manufacturers to respond to requests for verification of the serial number with respect to product that is voluntarily serialized in advance of the November 27, 2017. For example, if a product is voluntarily serialized in 2016, it may be difficult to respond to a request for verification of that product in 2018.”
“The difficulty in verifying such product can arise for many practical reasons related to normal operational practices, specifically, the nature of line-by-line implementation of serialization capabilities. For example, some manufacturers are currently, or will soon, serialize product produced on some packaging lines. Once each line is outfitted for serialization, manufacturers may elect to begin capturing the necessary commissioning data for serialization activity. However, each line must also be connected to data repositories as well as other IT systems; the manufacturer’s IT systems may not yet be fully developed and integrated to allow it to query the commissioning data—or at least not as quickly and efficiently—as it will be able to in November of 2017.”
“In other instances, the use of suppliers and contract manufacturers may create challenges for verification. These challenges have been noted particularly with foreign suppliers. For example, a foreign supplier may begin serializing product before the systems to share that information with the domestic manufacturer have been established. If, for example, the foreign supplier were to lose that data, the domestic manufacturer would not be able to verify the product, even though it is legitimate product.”
PDSA sees some similarities with the situation in early 2015 when the initial DSCSA requirements kicked in and some companies required a little more time to transition to the new systems and processes. At that time FDA announced that they would exercise “enforcement discretion” for a period of time, thus allowing them to keep the original deadlines, but also allowing companies to ease into the new requirements.
“PDSA is hopeful that the early identification of these challenges is useful and instructive for the Agency. We ask that the Agency exercise regulatory flexibility with regard to verification of the serial number for product that is voluntarily serialized before November 27, 2017. Such flexibility may include waiving the obligation to respond to requests for verification of the serial number for such product that is serialized early. Specifically, we ask that when a manufacturer faces challenges similar to those outlined in this letter, the agency permit the manufacturer to respond to verification requests by stating, ‘This product was packaged prior to November 27, 2017.’ ”
In a footnote, PDSA states:
“An unwillingness to exercise such flexibility would deter manufacturers from serializing product in advance of the November 27, 2017 [deadline], which is not a desirable policy outcome. Early serialization allows all trading partners to begin identifying and addressing challenges and will ultimately improve effective implementation of the DSCSA.”
WELL SAID, WELL PLAYED
PDSA is right to point out this potential problem as early as possible, in time for FDA to formulate a plan for enforcement discretion. Back when the FDA announced enforcement discretion each of 3 or 4 times in 2015, the announcement was made only a few days before the original deadlines (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”, “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015”, “FDA Extends Dispenser Delay in DSCSA Enforcement” and “FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders”).
If they offer new enforcement discretion of the type that PDSA proposes regarding verification, odds are, they will follow that same pattern. In that case, we won’t hear anything until around Thanksgiving, November 23. But you cannot count on receiving any enforcement discretion at all, let alone guidance. There are no guarantees.
Back in the middle of 2015, in one of my favorite RxTrace essays, I proposed a way of handling the serialization deadlines in several markets (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”). Better hope the FDA doesn’t like my idea!