FDA just issued its first DSCSA Warning Letter. Four years after the law’s verification requirements took effect, McKesson was cited by the agency for shirking its suspect and illegitimate product duties under the law. According to FDA, “The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires.” An obviously peeved FDA added, “This is simply unacceptable.”
FDA understands the significance of the DSCSA’s verification requirements and is sending a clear message to trading partners that non-compliance will not be tolerated. The agency warned, “A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law.”
I’m sure the agency has considered the wide-ranging implications of this incident. If McKesson has problems in this area, FDA should expect similar verification shortcomings, and probably much worse, with other trading partners, especially higher-risk secondary wholesale distributors and independent pharmacies. The scope of potential non-compliance is staggering and troublesome, especially considering the law is now more than five years old and trading partners have had plenty of time to establish DSCSA-compliant verification programs.
Unquestionably, the verification requirements for suspect and illegitimate products are the backbone of the DSCSA; its supply chain security and patient safety goals crumble without them. FDA clearly agrees with this assessment, adding, “These efforts are critical to protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful, as well as making sure these same drugs aren’t being diverted for illegal sale on the black market.”
FDA is certainly saying all the right things in this announcement, but their actions, unfortunately, tell a completely different story. Although the DSCSA’s verification requirements took effect on January 1, 2015, FDA is just now citing a trading partner for failing to comply with this part of the law. Four years. One Warning Letter. This is definitely not something to trumpet as an enforcement victory or promote as a meaningful deterrent to non-compliance.
It’s also hard to take the agency seriously when it warned, “FDA won’t hesitate to act when companies violate the law and jeopardize the safety of Americans by neglecting their responsibilities to maintain the security of the supply chain…” FDA probably should have left this part out until they had more than a single DSCSA Warning Letter to back it up. FDA will lose credibility and its warnings will be dismissed until the agency adopts a more aggressive DSCSA enforcement posture.
Lastly, assigning OCI agents to international mail facilities (IMFs) is great, but what about all the packages that slip through? Without a more secure supply chain and as long as apparent verification problems persist, counterfeit and unapproved drugs that evade detection at the IMFs will inevitably reach vulnerable patients. FDA should therefore use its limited agent corps to first tighten our nation’s pharmaceutical distribution supply chain. Forming such a shield should be the number one FDA objective. If that goal can be achieved, the mountainous volume of illicit IMF drug shipments will represent much less of a threat to legitimate patients.