According to the Drug Supply Chain Security Act (DSCSA), prescription drug wholesale distributors are not Authorized unless they comply with federal licensing and reporting requirements. Failure to comply with each of these requirements is prohibited by FDA and can lead to criminal penalties under the FD&C Act.
Detecting wholesalers that have not reported to the agency is no herculean task. Simply comparing records from state licensing authorities against FDA’s public database is all that it takes. The kind of work a capable intern could accomplish in a few weeks. Nevertheless, FDA enforcement action on this five-year-old mandate has been non-existent. Why is that?
By failing to enforce this basic requirement, the agency is unwittingly contributing to the flood of Suspect and Illegitimate Products within our supply chain. This happens when wholesale distributors that have not reported to FDA provide false Transaction Statements to their customers in which they claim to be Authorized. Any Products distributed in this fashion are likely Suspect and Illegitimate under the DSCSA because they are associated with Fraudulent Transactions (based on FDA’s proposed definition of the term). While failure to report to FDA may seem like a relatively minor infraction, the agency is sending the wrong signal when it engages in enforcement indifference on this issue.
Retired Navy Admiral William H. McRaven highlighted the significance of completing small tasks in his famous 2014 “Make your Bed” commencement speech. His speech included the following sage advice:
“If you make your bed every morning, you will have accomplished the first task of the day. It will give you a small sense of pride, and it will encourage you to do another task, and another, and another. By the end of the day, that one task completed will have turned into many tasks completed. Making your bed will also reinforce the fact that little things in life matter. If you can’t do the little things right, you’ll never be able to do the big things right…”
Tackling routine wholesale distributor reporting violations could inspire FDA to pursue more complex pharmaceutical distribution supply chain security challenges involving corrupt secondary wholesalers and independent pharmacies. But we’ll never know unless the agency can first learn to make its bed!