While many of us are gearing up to celebrate Thanksgiving this week, FDA is likely focusing its attention squarely on meeting three key milestones under the Drug Supply Chain Security Act. Specifically, FDA has until November 27th to issue national standards for wholesale distributor and 3PL licensure, as well as guidance on obtaining waivers from the DSCSA’s requirements related to product tracing, product identifiers, authorized trading partners, and verification. However, these standards alone will not secure our troubled supply chain; much more needs to be done. Protecting patients from the growing prescription drug diversion and counterfeiting threat requires FDA to exhibit the sort of leadership, bold action, and resolve that was lacking in the years leading up to the New England Compounding Center catastrophe. When serious risks to the health and safety of patients and consumers are known to exist, the public looks to FDA to protect them, even if the agency may face challenges in doing so.
Unfortunately, FDA’s inability to meet its DSCSA mandates in a timely fashion suggests the agency is overwhelmed and may lack the resources needed to establish compliance with the DSCSA’s requirements and deter supply chain crimes by corrupt trading partners. For instance, FDA’s public database of authorized wholesale distributors was established about nine months late, suspect product guidance was issued about a week late, product tracing guidance was issued a day late, annual reporting guidance was issued about a week after 3PLs were required to report and only about three weeks before wholesale distributors were required to report, and guidance extending the product tracing compliance date for manufacturers, wholesale distributors, and repackagers was not issued until the day before the requirement was set to go into effect. Highlighting these shortcomings is difficult for me, but doing so will hopefully encourage FDA to address any resource issues which may be at the heart of these delays.
After all, savvy drug diverters and counterfeiters are continuously looking for weaknesses to exploit and may be further emboldened if FDA does not embark on a comprehensive and public strategy featuring collaboration with stakeholders, robust compliance initiatives, and coalition building. If these indispensable measures are not pursued, criminal activity of this type is poised to continue its precipitous increase and patient safety will continue to erode at an unacceptable rate.