Those who claim our nation’s drug distribution system is safer under the Drug Supply Chain Security Act (DSCSA) may have to change their tune. A recent FBI prescription drug diversion case suggests it’s just as vulnerable today as it was for 25 years under the Prescription Drug Marketing Act (PDMA). Misinformation among well-intentioned stakeholders may be to blame for these misguided claims, but self-serving tactics by savvy proponents of the status quo may also be the culprit.
The truth is, pervasive willful blindness among corrupt secondary wholesalers and their often-complicit independent pharmacy cohorts exists today, just as it did under the PDMA. The DSCSA has not vanquished historical oversight inadequacies that continue to fuel this chasm-like pharma supply chain threat. Unless FDA and state regulators resolve to adopt a different approach, vulnerable patients will continue to be at risk and criminal activity within our so-called secure supply chain will proliferate.
According to the FBI press release, four defendants were charged in a $70 million drug diversion case involving black market HIV medications. The press release added that large quantities of diverted prescription HIV medications were acquired on the black market and false documentation was created claiming the drugs had been sourced from licensed suppliers. How many times have we heard this story before? If any pharmacy recipients of these diverted drugs attempted to validate the bogus transaction histories they received from the defendants’ organization, this scheme would have been detected in its infancy. Apparently, that was not the case. How long will this cycle of supply chain security futility and regulatory neglect continue?
Until FDA takes a stand on pro-active transaction history validation and due diligence, we can all expect that the DSCSA will be just as ineffective at protecting patients from diverted and counterfeit drugs as the PDMA.