Track And Trace Deadline Could Slip Again After Worries Over Inferencing

Generic representative raises concerns about errors from bulk scanning, while distributors and pharmacies feel failure to include inferencing will hinder patient access to drugs.

Industry is already pessimistic that an electronic, interoperable system to trace drug products at the package-level will be in place by in the US by 2023, and disagreements among trade partners could make achieving that reality even more difficult than it already is.

At the first of three US FDA public meetings on the Drug Supply Chain Security Act (DSCSA) – which lays out a timeline for implementing such a system – drugmakers appeared to be at an impasse with distributors and pharmacies over whether the system should include the practice of inferencing. The concept of inferencing refers to the ability to know what serialized drug products are inside of a package without having to open it.

Mark Hendrickson, senior director of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), said at the Aug. 23 meeting that many of his organization's members would be concerned about patient safety with a system that relies heavily on inference.

"Assuming a US unit volume of approximately 5 billion scripts annually, even at 1% throughput error, could result in 50 million errors per year, approximately 227,000 per business day," Hendrickson said, adding that some of AAM's members forecast a 6% error rate.

"Error rate could really impact the flow of product to patients," Hendrickson added. "It could impact good products getting to patients. It significantly adds costs to entire the system, not just manufacturers, but to everyone. It also takes a lot more time to implement that type of a system."

In responding to an FDA panelist, Hendrickson said that the forecast he mentioned was only "an envelope type of estimate," but that AAM is looking at conducting a study as part of a deeper look into the matter.

Chris Smith, however, director of federal public policy for the National Association of Chain Drug Stores (NACDS), contended that aggregation inference needs to be a "critical " part of the system given the large quantity of products involved.

"If you want to see patient access hurt, if you want to see a slow-down in the supply chain, then don't do aggregation and inference," Smith said.

"Because of the volume you are dealing with, not having be able to rely on inference, then it is going to slow to a snail's pace.

Healthcare Distribution Alliance (HDA) senior vice president of regulatory affairs Anita T. Ducca concurred.

"We are talking about literally tens of thousands of products going out a day, and it would just not be feasible to do it any other way," Ducca said.

When pressed by an FDA official on how they would respond to Hendrickson's argument on the error rate, however, Smith and Ducca said they would have to get back to the agency, with Ducca noting that HDA has "not progressed that far along."

The disagreement could be problematic in the ultimate formulation of the interoperable system. As Ilisa Bernstein, deputy director of FDA's Office of Compliance, explained, "As we work toward building this system, we need to agree at some point what that system is going to look like so we can move forward and figure out what the details are and the requirements."

A Pessimistic Outlook

When Bernstein asked the industry panelists how much work they feel needs to go into reaching the 2023 vision of the system, they resoundingly agreed it would take a tremendous amount of effort.

"From our perspective, I'd say quite a bit of effort still needed," Hendrickson said.

"There are some initial and short-term requirements that we are still trying to figure out that have impacted our ability to really look long-term."

Smith noted that, "unless things change soon … unless we have more depth in terms of the FDA's vision by 2018, I have serious doubts that the 2023 track is feasible."

"Time is ticking, and I have concerns that there is substantial work to be done across all sectors here, and I don’t have a high level of confidence that it can be done in five years unless things change soon."

Industry representatives were particularly frustrated that FDA has not yet issued guidance on the grandfathering of products. DSCSA – which became law in 2013 – directed FDA to finalize a guidance on grandfathering no later than two years of enactment of the law.

The industry panelists also cited the need for FDA to develop regulations establishing standards for licensing of third-party logistic providers and of wholesale drug distributors, which the agency expected to have done by September 2015.

"What's happening is our experts are being distracted by trying to discuss with what is going to happen to grandfathered products without those guidelines," Ducca said.

Bernstein did lay out the agency's broad vision at the start of the meeting, which included five pillars:

• Provide increased public health benefits;
• Ensure diligence and vigilance by all trading partners;
• Support FDA's compliance and enforcement efforts;
• Be adaptable and flexible; and
• Be interoperable with the health care system and global marketplace.

(More details on the pillars are provided in the table at the end of the story.)

Smith, however, still called for more clarity on FDA's vision of interoperability by mid-2018 to meet the 2023 deadline.

He said time is already "crunched," pointing to FDA's one-year delay in enforcing DSCSA's requirement for manufacturers to affix or imprint product identifiers. DCSA requires that manufacturers include product identifiers beginning Nov. 27, 2017, but FDA said in a June draft guidance that it would not take any enforcement action before Nov. 26, 2018 on this requirement. (Also see "Track & Trace – And Delay: Pharmacies Get Enforcement Discretion From FDA" - Pink Sheet, 30 Jun, 2015.)

Although Smith said NACDS didn't oppose the agency's delay in enforcement, he noted it "continues to crunch the timeline even further."

"It gives us less time to work with the dispenser level downstream," Smith said.

Areas Of Agreement

Despite the general pessimistic tone among the industry panel, there did appear to be a few aspects of a vision where members reached a consensus. For instance, there appeared to be agreement that an interoperable system should be decentralized, meaning data is stored across multiple databases.

"From our perspective, one of the main reasons [to have a decentralized system] is the security of the data, so it is not all in one place, and therefore it is easier to keep it secure in multiple locations," Hendrickson said.

Smith agreed that a decentralized system is better for security reasons, while also adding that he doesn't feel it is possible to make a change toward a centralized model at this point given the limited time to make the switch and the fact that the current system "works in a distributed fashion."

For her part, Ducca said that she believes Congress would have specified a centralized system in the law if that is what it wanted.

Industry panelists also pushed for a "sector-neutral governance," meaning that there is no one sector pushing its own needs ahead of those of others.

FDA's Interoperable System Vision
Provide increased public health benefits	The system needs to prevent the introduction of illegitimate products, to detect suspect and illegitimate products, and to rapidly respond when such products are found in the drug supply chain. To prevent, FDA must know specifically what product is in the US drug supply, where it has been, where it is going and who is handling it and ensure that only legitimate, uniquely identified product moves through the drug supply chain by trusted authorized trading partners. To detect, electronic systems and processes at every node in the supply chain should be able to generate red flags when suspect or illegitimate products are identified. To respond, data and information about the product and related transactions should be quickly and readily available electronically to ensure prompt investigations of those red flags for follow up.
Ensure diligence and vigilance by all trading partners	The electronic system should be a sentinel system to enable identification of breaches, protect suspect and illegitimate product, and facilitate red flags. Authorized trading partners have obligations under the law that helps to ensure the security of drugs in the supply chain, including the electronic exchange of transaction documentation and verification. Identifying the right balance of diligence and vigilance will be important in order to catch suspect and illegitimate products in the supply chain without disrupting the availability of movement of drugs for dispensing or final disposition.
Support FDA's compliance and enforcement efforts	FDA needs to be able to have rapid access and visibility to the data and information of where the product has been in order to meet our obligation to protect the public health. Information technology advancements that ensure privacy and security of information across diverse sectors of the marketplace should be incorporated into the 2023 system.
Be adaptable and flexible	As information technology advances, the system should be able to advance without significant disruption to drug distribution and added costs.
Be interoperable with the health care system and global marketplace	There are a number of opportunities to consider for future linkages or leveraging that can improve patient care and help rein in increasing prescription drug spending. As electronic health records are becoming ubiquitous throughout the healthcare system, accurate recording of prescription drugs for dispensers could provide insight into what was prescribed and minimize medication errors. Automated prescription drug coverage at pharmacies, hospitals and other healthcare centers can be leveraged and be a cost-saving measure such that payers would only pay for specific uniquely identified drugs. Health fraud issues could also be identified.