FDA’s proposed national wholesale distributor licensing standards are almost three-and-a-half-years overdue and it’s becoming apparent the agency has no intention of issuing them any time soon.  According to CDER’s 2019 guidance agenda, these standards are not on the agency’s radar for the remainder of the year.  Maybe it will happen in 2020.

Under the DSCSA, FDA was mandated to establish national wholesale distributor licensing standards by November 27, 2015. It’s now 2019.  So, what gives? Why is something so important being handled so poorly (at least from my perspective)? Neglecting this DSCSA pillar could lead to disastrous consequences for patients.  Without robust standards and oversight, corrupt wholesale distributors will continue to thrive, operating as unfettered conduits of diverted and counterfeit drugs within our supply chain.  To make matters worse, the extent of this problem and its impact on patient safety remains largely unknown.  How could that be after 30-plus years?

When the Prescription Drug Marketing Act was passed in 1987, Congress found “The integrity of the distribution system for prescription drugs [was] insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.”  Congress added, “The existence and operation of a wholesale submarket, commonly known as the ‘diversion market,’ prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases.”

Almost twenty years later, these warnings were echoed by The American Council on Science and Health in an August 2006 report, titled “Counterfeit Drugs: Coming to a Pharmacy Near You.”  This powerful and comprehensive report found, “There has yet to be a nationwide effort to tighten wholesale licensing standards, an essential step if the criminal element is going to be driven out of the industry. Tighter licensing requirements and mandatory due-diligence practices for secondary wholesalers will help to strengthen this weakest link of our drug supply chain.”

Thanks to the DSCSA, FDA has had the authority to solve this problem for several years now.  But it seems like 1987 all over again.  The agency’s lackluster DSCSA oversight and enforcement strategy resembles its approach under the PDMA.  This historical leadership vacuum on pharmaceutical distribution supply chain issues may someday spawn an incursion that dwarfs the counterfeit Avastin and Altuzan cases of 2012 and 2013.  Luckily, we’ve been spared from such an event.  But how long will that good fortune last?

See my previous posts on this topic here and here.