Where have you gone, draft DSCSA guidance? FDA’s position on DSCSA verification systems was announced last October but went MIA from the agency’s dedicated web page a few months ago. A web site overhaul in April is the likely culprit, but the powerful influence of status quo supply chain forces should not be completely discounted either. Perhaps, it was pulled after strenuous objections from certain stakeholders, maybe even some of the same ones that helped torpedo the PDMA.
In this key DSCSA-related guidance document, FDA assigns a due diligence obligation on trading partners that is not expressly present in the law’s verification requirements for suspect and illegitimate products. Unfortunately, these cornerstone DSCSA requirements are not triggered until a determination is made that such products are in a trading partner’s possession or control. It is simply unrealistic, however, to expect the DSCSA to reach its supply chain security zenith if trading partners are not also required to identify suspect products. This, of course, represents the ultimate DSCSA paradox. Trading partners should not be expected to make suspect product determinations with greater frequency if there is no parallel requirement under the law to identify suspect products in the first place.
Despite this glaring DSCSA disconnect, FDA’s draft guidance states that trading partners must have systems in place “to enable them to identify and determine whether a product is a suspect product.” FDA adds it is essential that such systems “be well-designed to detect and assess suspect product…” This language is clearly proactive in nature. Bravo FDA for making this bold and crucial leap for patient safety!
While it is entirely reasonable for FDA to interpret the law’s verification requirements in such a fashion, strict interpreters of the law may have cried foul. Those outside voices may be quite loud and powerful at times. It will be interesting to see when this MIA guidance document re-appears on the agency’s web site and if any changes are eventually made to FDA’s position on due diligence. I’m hoping that FDA sticks to its guns. If not, the DSCSA will continue to be viewed by supply chain predators as a sheep in wolf’s clothing.