IPEC Urges Track and Trace Mandates, But Will They Materialize?
In June, Victoria Espinel, Intellectual Property Enforcement Coordinator (IPEC), Office of Management and Budget, testified before Congress about drug counterfeiting. Her office is establishing an interagency committee to combat counterfeiting, and her team will take on unlicensed Internet pharmacies and counterfeit drugs both in the United States and around the globe. “And to further guard against the proliferation of counterfeit drugs, we will increase our enforcement efforts and cooperation with relevant agencies, including CBP, DEA, and FDA,” she testified.
In fact, the 2010 Joint Strategic Plan on Intellectual Property Enforcement states that the Food, Drug, and Cosmetic Act should “be modified to require that manufacturers, wholesalers, and dispensers implement a track and trace system, which allows for authentication of the product and creation of an electronic pedigree for medical products using unique identifiers for products.”
Will such recommendations actually lead to anticounterfeiting mandates? Some analysts believe so. “We are already seeing vigorous activity from FDA on this front,” says Daniel R. Matlis, president, Axendia (Yardley, PA). “The agency is currently looking at the body of legislation to see how much more strongly it can enforce it. For example, FDA has already opened offices around the world to get boots on the ground.”
To mandate the use of anticounterfeiting or antidiversion technologies, FDA would, of course, need Congressional effort to change food and drug law, Matlis notes. Ahead of mandates, Matlis is observing “significant cooperation and alignment between industry and regulators as companies look for a cooperative, interoperable approach to address supply chain issues,” he notes. “Consortia like Rx-360 are making significant inroads bringing life science industry stakeholders together. There is a real appetite to collaborate among brand owners, distributors, regulators, and standards development organizations.”
And some of the companies Axendia advises are “making significant investments to bring about visibility in their own supply chains,” Matlis says. Some of these firms are also adding new corporate roles, such as a brand protection officer. This is top-of-mind for industry executives. We see senior executives in finance, quality, marketing, operations, and IT getting involved in securing the global supply chain.”
Gaps do remain, however. “Supply-chain links get broken, so without complete visibility, security and financial issues persist,” says Matlis. “Gaps are present in the interfaces, and the chain of custody is sometimes broken and unclear. Weaknesses exist in the path from raw materials to manufacturers to distributors to pharmacies, so medical practitioners and patients don’t always have visibility. They cannot readily verify what is in the amber vial.”
Just what do I mean by a lack of visibility? FDA reported in August that Carbatrol and Adderall XR stolen en route from Shire Pharmaceutical’s manufacturing facility in North Carolina to its distribution center in Kentucky “has started to appear in expired returns and more stolen product may still be on the market.” Where did it go? How did it end back up in the supply chain? And was any of it used by patients prior to expiration dates?
So are mandates the only way to achieve complete visibility? Perhaps. A standardized, mandated, and harmonized system could be the surest means toward a predictable, manageble, and visible path through the global supply chain. To pull it off, though, IPEC’s work with U.S. agencies will need to extend to regulators and others around the world. But maybe that is why FDA is putting boots on the ground in India, China and beyond?