In October 2017, FDA quietly issued a suspected counterfeit Harvoni notice to pharmacies in the Philadelphia area, but apparently decided against warning the broader public by posting it to the agency’s web site.  In fact, the notice is non-existent on the FDA web site, suggesting FDA was trying to minimize the impact of this incident, or even bury it.  But why?  It took a Google search for “counterfeit Harvoni” to find a link to the notice on the PA Board of Pharmacy web site.

FDA’s notice alerted Philadelphia-area pharmacies “to check any inventory they purchased from 52nd Street Pharmacy since January 1, 2017.”  The notice added that “52nd Street Pharmacy may have sold counterfeit prescription drugs to other pharmacies in the region.” At the time of the notice, FDA knew only that “52nd Street Pharmacy may have sold a bottle of Harvoni (ledipasvir/sofosbuvir), a hepatitis C drug, to another local pharmacy that contained the wrong medication.”  Interestingly, this happened to coincide with a string of counterfeit Harvoni incidents in Germany, Switzerland, Israel, and Japan.

FDA explained it was providing the warning because “52nd Street Pharmacy may have sold other drug products that do not contain the medication that was supposed to be in the bottle.”  FDA added, “There is no indication that Gilead’s FDA-approved Harvoni is at risk, and FDA believes that the authentic product remains safe and effective for its intended use.”  The potentially counterfeit Harvoni reportedly had a lot number of 006170 with an expiration date of 12/2017, and the tablets were orange, oblong-shaped, with a “C” on one side of the tablet and no imprint on the other side.

Perhaps FDA’s unusual handling of this notice was designed to protect the integrity of an ongoing inter-agency criminal investigation, while at the same time striving to meet its public health mandate. This is certainly a plausible explanation, considering the owner of 52nd Street Pharmacy was indicted on controlled substance violations in January 2017.  Nevertheless, this incident bolsters the notion that under-regulated independent pharmacies are a massive supply chain vulnerability.  More transparency from FDA, not less, is needed to draw attention to this lurking public health crisis.

This suspected counterfeit Harvoni incident has all the earmarks of a drug diversion scheme in which previously-dispensed prescription drugs (the non-controlled and expensive type) are purchased by corrupt independent pharmacy owners from illegitimate suppliers.  These diverted drugs often originate from Medicaid recipients who sell them to “collectors” and “aggregators” before they are sold back to shady pharmacies and wholesale distributors. The safeguards of the DSCSA become meaningless in this murky sub-market, a chilling supply chain blind spot of unknown scale. During these illicit transactions, different drug products may be secreted into authentic bottles and counterfeit labels may be utilized to disguise damage to such bottles as a result of the diversion process (i.e. removing patient labels).

When corrupt independent pharmacy owners engage in this type of insidious activity, the counterfeit drug threat to vulnerable patients increases exponentially. As I recently posted, foreign-sourced counterfeits may already be flowing through our porous international mail facilities and into the hands of diverters before finding their way onto the shelves of independent pharmacies, like 52nd Street Pharmacy.  Ultimately, these counterfeits will end up in the homes of vulnerable patients when greedy independent pharmacy owners eschew patient safety for profits.

Federal and state regulators who choose to dismiss such a scenario as unlikely are engaging in a dangerous form of denial, a major contributing factor in the 2012 NECC compounding catastrophe.  The counterfeit and diverted drug threat from hundreds, or even thousands, of independent pharmacies located throughout the country exists and must be publicly acknowledged by FDA and its state counterparts.  Failing to do so is irresponsible in the face of a growing body of criminal supply chain cases involving independent pharmacies.  The activity that prompted FDA to issue this suspected counterfeit Harvoni notice is happening on a much larger scale and will lead to tragic consequences without a coordinated plan at the federal and state level to address this threat in earnest.