In a series of communications between FDA and McKesson, culminating in a statement by FDA Commissioner Scott Gottlieb on Feb. 12, McKesson has been accused of noncompliance with a variety of rules embedded in the Drug Supply Chain Security Act (DSCSA). A warning letter had been written in July, with followups between the agency and the company, the No. 1 wholesaler in the US, in later months. Charges include not providing suitable response when notified by multiple Rite Aid pharmacies (tracing back to 2016) that oxycodone bottles being received had broken seals and were empty or filled with other products. Also in 2016, two bottles of a GSK product, Triumeq, and bottles of losartan and divalproex, were delivered to various pharmacies that were either mislabeled, or contained a different product. (it’s not clear whether, in these cases, McKesson had repackaged the products.)
DSCSA rules dictate that wholesalers dealing with suspect product are supposed to quarantine that lot, conduct investigations, report findings to FDA, and document and store records of subsequent actions. The FDA Form 483 letter notes that McKesson took multiple actions in response, yet did not comply with the letter of the law. According to FDA, McKesson told FDA that, concerning the oxycodone diversions, “incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm”—which is not DSCSA policy.
“This is simply unacceptable,” stated Gottlieb on Feb. 12. “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.” It’s worth noting that a Form 483 letter is only occasionally the beginning of a legal action against a manufacturer or distributor, and even when legal action is taken (by, for example, involving the Dept. of Justice), the outcome is not foreordained. McKesson hasn’t issued any public statement about the matter.
The shame of this dispute is that McKesson has been a leader in helping the entire US wholesaling industry (and, indirectly, manufacturers) in developing compliance programs for DSCSA. It has been a longstanding participant in the Healthcare Distribution Alliance’s work group developing industry practices, which is occurring because compliance is of necessity a shared burden by manufacturers, wholesalers, pharmacies and others—the entire US drug supply chain.
Some commentators on the matter suggest that wholesalers, as a group, are still just beginning to recognize their dealings with FDA that began with DSCSA; previously, many regulatory actions were dictated by state boards of pharmacy. Many wholesalers—including McKesson—have been caught up over the years in enforcement actions by DEA; however, the interactions between FDA and wholesalers had been going on for years prior to the passage of DSCSA in 2013, and certainly since then.