The holdup on an interoperable, electronic, serialized, track-and-trace system that will have a global reach for prescription drugs sold in the U.S. market is much more basic than supply and demand. It's a matter of settling on a vision of what that system should look like in the face of ever-evolving technology.

Regulators, drug manufacturers, wholesalers, distributors and pharmacists expressed their views Wednesday at the first in a series of three meetings the FDA is holding on the creation of the track-and-trace system mandated by the 2013 Drug Supply Chain Security Act (DSCSA).

As the FDA shared discussion starters on what the vision could entail, several stakeholders pleaded for much-needed guidance, hinting at the unspoken question in the room as to why this dialogue wasn't held four years ago, especially when the system is supposed to be fully operational by 2023.

"We don't have guardrails from the FDA," said Chris Smith, director of federal public policy for the National Association of Chain Drug Stores. Unless trading partners in the drug supply chain have FDA answers soon on what it expects, having an interoperable system in place by 2023 is doubtful, he warned.

"We're concerned that time is already crunched," Smith said, referring to the FDA's recently announced year-long delay in enforcing the first step, which requires drug manufacturers to affix or imprint a product identifier – consisting of the product's standardized numerical identifier, lot number and expiration date – on each package and case of drugs intended for the U.S. market.

The DSCSA had given manufacturers until Nov. 27 to have that serialization process in place. In extending a grace period until November 2018, the FDA cited a lack of industry readiness, due in large part to the limited vendors, equipment and software that were available to meet the demand and the relatively short time frame to install a serialization system. (See BioWorld, Aug. 17, 2017.)

While that extension will help manufacturers, it could affect other members of the supply chain facing subsequent deadlines under the DSCSA, Smith noted.

Questions abound

The FDA has issued some guidance to help shape a track-and-trace model intended to protect against counterfeit drugs and facilitate recalls. For instance, it released a draft guidance on interoperability standards in 2014. But given the ongoing technological evolution, the FDA's Ilisa Bernstein asked stakeholders at Wednesday's meeting whether the interoperability definition given in that guidance would change when a fully electronic system is in place in 2023.

That led to more questions. Would interoperability be required among all the trading partners or between two of them? Also, is the FDA now part of the supply chain? Will state and federal regulators have direct, unfettered access to the system? Or will they have to ask for the data?

Point-to-point interoperability is much different than a centralized system that makes all the transactional history available to anyone who's touched the product, several stakeholders said. Not only would a centralized system be a sea change, it could be more susceptible to hackers than a distributed system would be, they pointed out.

Others asked who would pay for a centralized system and who would maintain it. And some stakeholders insisted that such a system would exceed the limits of the DSCSA. However, FDA officials noted that while the law may not specifically say something is allowed, that doesn't mean it's prohibited.

FDA vision

In getting the conversation started, the FDA shared its vision for a track-and-trace system, with Donald Ashley, director of the Office of Compliance at the agency's drug center, acknowledging, "The FDA cannot build the system alone."

Bernstein echoed that call to partnership. "We must work together to get this right," she said. "We need to be forward thinking and push ourselves to design a system that's not based on the lowest hanging fruit."

Rather than providing specific features such as a centralized system vs. a distributed system, the FDA vision provides broad goals, calling for a closed system that will:

  • • provide increased public health benefits by keeping good drugs moving through the system while stopping illegitimate drugs in their tracks;
  • • ensure diligence and vigilance by all trading partners;
  • • support the agency's compliance and enforcement efforts;
  • • be adaptable and flexible;
  • • be interoperable with the health care system and global marketplace.

In explaining the agency's vision, Bernstein described a system that could show what drugs are in the chain, where a drug has been, where it is at that moment and which trading partners have been involved in handling it. Such a system would give the FDA rapid access to information on where a drug is in the supply chain, allow companies to better manage inventory, facilitate recalls, help prevent shortages, rein in drug spending, limit medical errors and potentially reduce fraud, she said.

To realize those benefits, a track-and-trace system needs to incorporate risk models and predictive controls to identify suspect drugs and raise red flags, Bernstein said. At the same time, it must allow legitimate drugs to move seamlessly through the chain regardless of the size of the trading partner and without being burdensome and increasing costs.

If the FDA wants to keep good drugs moving, it will need to distinguish between tracking errors, such as typos or a missing identifier, and truly suspect products. Throughput errors are to be expected, given the hefty volume of drugs moving through the supply chain, said Mark Hendrickson, senior director of sciences and regulatory affairs for the Association for Accessible Medicines.

With about 5 billion prescriptions being filled each year in the U.S., a 1 percent error rate would result in 50 million errors, Hendrickson noted, adding that the error rate likely would be closer to 6 percent. Unless the FDA provides reasonable ways to deal with errors, a lot of legitimate drugs could be stuck in warehouses instead of getting to the patients who need them.

Another worry is whether the FDA will allow downstream trading partners to infer package identifiers from an aggregate identifier or require them to open intact pallets of product so they can scan each package. Anita Ducca, senior vice president of regulatory affairs for the Healthcare Distribution Alliance, explained that distributors move 15 million prescription drugs each day to more than 200,000 pharmacies and hospitals. Opening each pallet to scan individual packages and then reassembling the pallet would cause considerable delay in moving the product, she said.

Stakeholders will be asked to weigh in more specifically on these and other issues when the conversation continues Dec. 5-6.

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