FDA is launching a DSCSA pilot project that will focus on technological-based solutions to supply chain security. According to the agency, “This new program will pilot technologies that may become part of our enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.”
But this approach alone is no silver bullet. Without robust oversight by FDA and its state counterparts, diverted and counterfeit drugs will continue to threaten vulnerable patients. Innovations to product tracing and verification systems are crucial but they will not overcome longstanding regulatory inadequacies (ignoring them won’t help either). Deterring corrupt prescription drug distributors and pharmacies requires a more comprehensive strategy. Until FDA places a greater emphasis on its DSCSA oversight and enforcement requirements, bad actors in our supply chain will continue to thrive and avoid accountability.
Trading partners have probably invested hundreds of millions of dollars to establish compliance with the DSCSA’s product tracing, product identifier, and verification requirements. But they should not be the only ones shouldering the burden of supply chain security. FDA must do more. Holding meetings and issuing guidance documents are DSCSA mandates, but enforcing compliance with the law’s requirements is also an FDA priority. If they don’t do it, who will?
In its announcement, FDA Commissioner Dr. Scott Gottlieb stated, “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply.” Maybe one of these FDA “steps” could be issuing Warning Letters to wholesale distributors that have not reported to the agency and are not Authorized under the DSCSA. This is the lowest of low-hanging fruit. A DSCSA-compliance slam dunk.
As Dr. Martin Luther King Jr. stated, “If I cannot do great things, I can do small things in a great way.” Warning Letters are a relatively routine FDA enforcement action. These small things could lead to something great, like identifying and weeding out corrupt wholesalers. Who knows what will happen after that? But the end result could be even greater!