The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA). I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation.
This warning letter offers a glimpse into how the FDA expects companies to respond to suspect product and illegitimate product notices. In short, they expect your full and immediate attention, and for you to follow your pre-written Standard Operating Procedures (SOPs) that address the requirements of the law, including quarantine, notice to trading partners, investigation and record-keeping.
I’m not going to review here each infraction the FDA documents in the letter. It makes more sense for everyone to just read the FDA’s words rather than for me to regurgitate them here. In addition to my original explanation of the McKesson 483, here are the links to the new warning letter and some articles that others have written about it:
- FDA’s warning letter to McKesson, February 7, 2019
- RAPS article about it by Zachary Brennan , February 12, 2019
- LSPediA blog essay by Riya Cao about it, February 13, 2019
- Statement by FDA Commissioner, Scott Gottlieb, that links the McKesson violations to the opioid crisis, February 12, 2019
McKesson’s bad luck with this situation continues to grow. One of the violations documented in the warning letter dealt with an opioid drug that was apparently tampered with/stolen while it was under McKesson’s possession or control. When they learned of the tampering/theft, they did not follow multiple DSCSA requirements. That left the company open to having these deficiencies further exposed in Commissioner Glottlieb’s statement this week on FDA’s efforts to stop the illicit sale and distribution of opioids.
“[What McKesson did] is simply unacceptable.” –Commissioner Gottlieb.
I suspect part of the problem is that wholesale distributors may still be in denial that so many of their actions now fall under the purview of the Federal Government. Prior to the passage of the DSCSA the main regulatory agencies they had to deal with were the DEA and the state Boards of Pharmacies. Because there are 50 of those Boards, each of their distribution centers had to interact with their local Board for licensing and compliance.
Now that the FDA is responsible for enforcing the DSCSA, the regulatory people at these local distribution centers must be put through significant re-training. Each DC should have a designated expert on the wholesale distributor requirements of the DSCSA and must own the SOPs needed to keep them in compliance, especially when bad things happen. The corporation must stay in continual contact with these experts to ensure they are all kept in tight alignment with the corporation’s DSCSA policies and SOPs, and to participate in any local DSCSA compliance activities…like when a customer says they received suspect products…and when an FDA inspector shows up at the DC and asks about DSCSA-related things.
This warning letter should also be carefully reviewed by all dispensers as well. It is widely recognized that dispensers of every size have not been paying much attention to the DSCSA and very many are not aware of their obligations under it (of course, there are exceptions). This warning letter makes an example out of McKesson, not just for wholesale distributors, but for everyone in the supply chain—including dispensers. Who will be next to have the FDA’s spotlight focused on their DSCSA compliance activity?