FDA Stepping up Track and Trace Efforts—But Will the Agency Need More Authority Before Taking Action?

As it digests stakeholder suggestions for a track-and-trace system for prescription drugs, FDA released through its new Office of Drug Security, Integrity, and Recalls (ODSIR) the preliminary report, "Review of Counterfeit and Diversion Criminal Case Information—September 2011." The report states that while the U.S. drug supply chain is "one of the safest in the world," it is "increasingly vulnerable to a variety of illegal activities." These include counterfeiting and diversion schemes.

For instance, FDA recounted how one pharmacist in Texas ordered counterfeit Viagra and Cialis from China. The pharmacist was convicted in 2006 of conspiracy to introduce in interstate commerce counterfeit and misbranded pharmaceutical drugs and trafficking in counterfeit drugs from China. FDA also cited a conspiracy lasting through 2005 that involved illegally obtaining unused or stolen prescription medications and selling them to wholesalers in New York, Utah, and Texas or through pharmacies in New York and elsewhere.

If these crimes seem a bit dated, consider these statistics shared by ODSIR director Michael Levy during the virtual event, "Pharmaceutical Track and Trace and Authentication": in 2009, FDA's Office of Criminal Investigations opened 65 counterfeit drug cases, while in 2010, it opened 72 cases.

Levy explained during the event that the drug supply chain remains vulnerable to having "stolen product reintroduced, counterfeit/falsified drugs sold to suppliers, diverted drugs resold, or other adulterated/misbranded drugs introduced."

For example, in May, Greenstone products were stolen "while being delivered from Pfizer's Memphis facility to a customer in the Northeast," FDA reported.

In June, Abbott Diabetes Care had "one tractor-trailer shipment of blood glucose monitoring products reported stolen from a shipping carrier facility in Louisville, KY," FDA reported.

Even the OTC drug product supply chain is vulnerable. In late August, a trailer was stolen as it stopped along on its way to a Johnson & Johnson Distribution Center in Mooresville, IN. It held such Johnson & Johnson Consumer products as Monistat, Reach, Cortaid, Aveeno, Neutrogena, and Johnson & Johnson First Aid to Go!, FDA reported. Also in August, a Tennessee man was arrested and charged with obtaining and selling counterfeit Viagra and Cialis. The man allegedly made wire transfers to pay for the counterfeit drugs.

FDA is working to address these threats through its new office. ODSIR is reviewing comments submitted to the agency after its track-and-trace workshop earlier this year, after which FDA had extended its comments period through June 22. Comments were accepted at http://www.regulations.gov under docket number FDA-2010-N-0633.

Whether new legislation is needed for FDA to take action is unclear. During her testimony before the United States Senate Committee on Health, Education, Labor and Pensions on September 14, Deborah Autor, FDA's Deputy Commissioner for Global Regulatory Operations and Policy, stated that "in general, new regulatory authorities may help ensure that industry takes principal responsibility for the security and integrity of its supply chains and the quality control systems it uses to produce drugs for the American people. In an era of globalization, new authorities can help to level the playing field between domestic and foreign manufacturers, ensure product safety and provide FDA with the information it needs to protect consumers."

Among those authorities is "requiring a cost-effective track-and-trace system for all drug products throughout the supply chain [that] would improve the security and integrity of the drug supply and ensure transparency and accountability of product manufacturing and distribution, whether the product is manufactured domestically or internationally," Autor explained.

Interestingly, as we countdown toward California's deadlines beginning in 2015, the California State Board of Pharmacy "is hopeful that the FDA can move very quickly to establish national standards," wrote Stanley Weisser, CA BoP president.

While waiting for such national standards come to pass, however, California's BoP will resume its electronic pedigree development in a work session on December 6, says Virginia Herold, executive director, California's State Board of Pharmacy, reports PMP News senior editor David Vaczek.

Daphne Allen
Editor, PMP News
daphne.allen@ubm.com

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Consider Action Before Federal Mandates

There is still no federal mandate for a track-and-trace system for pharmaceuticals, but federal interest in securing the pharmaceutical supply chain continues to grow. Last week FDA introduced a strategy for maintaining quality in the global supply chain, just as the U.S. Department of Homeland Security weighed in on counterfeiting threats. And, to remind us of what the threats really are, Health Canada reports that the Royal Canadian Mounted Police seized counterfeit Cialis in the greater Toronto area that same week.

FDA's new global strategy to ensure safety and quality of imported products calls for greater agency activity around the world. FDA has initially identified four tasks as part of that strategy, detailed in its report "Pathway to Global Product Safety and Quality," and they appear to suggest that product visibility and information will be necessary. We wonder whether any of the below tasks would tie in with FDA's "ongoing efforts to develop standards for further securing the drug supply chain?"

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

Could a federal track-and-trace system harmonized with global standards help FDA accomplish these tasks?

Meanwhile, representatives from the U.S. Department of Homeland Security (DHS), Pfizer Inc., and Eaton Corp. met at the National Press Club in Washington, D.C., to discuss counterfeit threats. According to a press release issued by Eaton, panelists included: William G. Ross, unit chief, field support unit, National Intellectual Property Rights Coordination Center (IPR Center) - U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI), U.S. Department of Homeland Security; Patrick Ford, senior director, Americas Region - Pfizer Inc.; Tom Grace, manager, Anti-Counterfeiting and Brand Protection - Eaton Corporation; and Kevin McLean, senior vice president, Global Marketing - Eaton Corporation. The panel addressed threats posed by counterfeit pharmaceuticals and electrical products, which DHS classifies as "safety and security items."

According Ross, the IPR Center serves as an ad hoc IP theft task force made up of representatives from 19 member agencies. "Leads come into us at the IPR Center, and then we hand over lead investigation to specific agencies. In the case of pharmaceuticals, we work with FDA's Office of Criminal Investigation as well as the FBI and others." Weekly meetings are held to review leads and initiatives.

The IPR Center also works directly with pharmaceutical companies, encouraging them to share leads about specific Web sites or other targets. "We encourage companies to take civil action, while we can coordinate criminal investigations," says Ross.

For instance, in June, a case that had been investigated by ICE HIS ended in the sentencing of a Chinese national to federal prison for trafficking in counterfeit versions of the pharmaceutical weight-loss drug Alli. In a statement issued in June, U.S. Attorney John Walsh, District of Colorado, stated that the "sentence demonstrates what can be accomplished when the FDA Office of Criminal Investigations, ICE Homeland Security Investigations, and U.S. Postal Inspection Service combine resources to investigate and apprehend an international criminal whose actions were harming Americans."

The ever-expanding supply chain shows that investigations may need to wrap around the globe. FDA Commissioner Margaret A. Hamburg M.D. described it best when introducing the agency's import safety strategy: "Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete. There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."

Deborah Autor, director of the Office of Compliance for FDA's Center for Drug Evaluation and Research, told PMP News that "FDA's global approach for product safety and quality is necessary to meet the challenges of an continually increasing global supply chain for medical products. This strategy includes collaboration, information sharing, and compatibility whenever possible with our international regulators to help protect and build a more secure global supply chain. While FDA will use new regulatory approaches to protect the drug supply and the public health, it cannot do this alone; pharmaceutical manufacturers should also consider new approaches to ensure the integrity of their products as business practices and processes may be significantly different from what they were just a decade ago."

As we pointed out in our last issue of Countdown, pharmaceutical companies have widened their view to take in much more than just the U.S. market.

"Our objective is to provide global end to end visibility of our product movement," Michael Rose, vice president, supply chain visibility, customer & logistics services, Johnson & Johnson, wrote to FDA in response to its February workshop, Determination of System Attributes for the Tracking and Tracing of Prescription Drugs. "Adoption of global standards is critical for maintaining global interoperability and visibility."

Added Mark Goldberger, divisional vice president, regulatory policy & intelligence, Abbott: "As a global company, we encourage the agency to consider a common global approach, where practicable. At a minimum, Abbott welcomes one uniform domestic standard."

Interestingly, FDA pointed to its work with the Global Harmonization Task Force (GHTF) as one of the "critical building blocks for the collaboration envisioned in this strategy for global product safety." The GHTF had drafted guidance on a Unique Device Identification (UDI) system that could be used around the world. "The GHTF guidance will provide a framework for regulators, including FDA," says Jay Crowley, senior advisor for patient safety, in FDA's Center for Devices and Radiological Health. "That framework is a global system, technology neutral, with core attributes that are the same around the world." (Please visit www.ghtf.org/ahwg/ahwg-proposed.html.)

Should a similar system be put in place for pharmaceuticals? Counterfeit drugs are being seized without one (see Health Canada's advisory on counterfeit Cialis, along with pictures of the counterfeit and authorized blister packages).

A uniform approach to identifying authentic pharmaceuticals, however, could go much further in ensuring safety throughout the global supply chain.

Daphne Allen
Editor, PMP News
daphne.allen@ubm.com

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Industry Encourages Federal Mandates

At its February workshop, "Determination of System Attributes for the Tracking and Tracing of Prescription Drugs," FDA invited supply-chain partners to provide input on potential approaches toward a system that could protect the drug supply chain against counterfeit and other substandard drugs. The agency has since received substantial input via docket number FDA-2010-N-0633. Stakeholders agree that a national approach to track and trace is needed (with some even suggesting global systems), but there is some disagreement on just who should be doing the tracking and tracing.

"We urge the FDA to act as quickly as possible in order to eliminate the uncertainty and significant investment of resources necessary to comply with California's requirements, which may not necessarily meet the future objectives of a track and trace system that [FDA] may propose," wrote Kendra Martello on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA).

"Industry is relying [on] the FDA to preempt CA with a more feasible phased approach," wrote a spokesperson for Three Rivers Pharmaceuticals. "Possibly exploring an 'end to end' approach with the more developed 'track and trace' system following within a reasonable timeline."

Pharma companies are looking beyond U.S. supply chains, too. "Our objective is to provide global end to end visibility of our product movement," wrote Michael Rose, vice president, supply chain visibility, customer & logistics services, Johnson & Johnson. "Adoption of global standards is critical for maintaining global interoperability and visibility."

Added Mark Goldberger, divisional vice president, regulatory policy & intelligence, Abbott: "As a global company, we encourage the agency to consider a common global approach, where practicable. At a minimum, Abbott welcomes one uniform domestic standard."

AstraZeneca suggests that the United States model its program after a pilot program conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in Europe. "We believe that the EFPIA Coding Project successfully demonstrated that a point of dispense verification model (i.e., unit serialization linked to a centralized database) could be implemented to verify products at the pharmacy level for government reimbursement," wrote David Buynak, serialization program leader—North America, AstraZeneca Pharmaceuticals LP.

Such a "point-of-dispense" system, however, concerns the National Association of Chain Drug Stores (NACDS) given packaging differences between the U.S. and European markets. "We are not supportive of verification and authentication at the point of dispensing," wrote Diane Darvey, director, federal and state public policy. "While some stakeholders may have provided European examples of pharmacy level authentication, they fail to recognize the key differences between that pharmacy market and the U.S. retail pharmacy environment. In Europe, unit of use prescription drug packages are used for dispensing. Conversely, this is not the situation in the U.S. retail pharmacy environment. Given these differences and the other differences in U.S. pharmacy dispensing systems, we do not support pharmacy point of dispensing verification and authentication because it would be unworkable."

Instead, NACDS believes "that pharmacies should be permitted to rely on their supply chain partners (e.g., wholesale distributors, drug manufacturers, and their logistics partners) to perform the necessary authentication and verification and quarantine any unfit products before distribution to the pharmacy."

Of course, such debates may be a bit too early. While FDA has the authority to develop track-and-trace standards, it may "require additional legislative authority to develop regulations," noted Martello of PhRMA.

Legislators have proposed a number of bills that could give FDA that power. The Pharmaceutical Market Access and Drug Safety Act of 2011, sponsored by Senator Olympia Snowe (R-ME), could lead to requirements pertaining to the identification of drug custody throughout the supply chain. The law's language suggests that it could be used to propel track-and-trace or anticounterfeiting mandates. "The Secretary shall by regulation establish requirements . . . to identify the chain of custody of a drug . . . from the manufacturer of the drug throughout the wholesale distribution of the drug to a pharmacist who intends to sell the drug at retail if the Secretary determines that the alternative requirements, which may include standardized anti-counterfeiting or track-and-trace technologies, will identify such chain of custody or the identity of the discrete package of the drug from which the drug is dispensed . . . and that the alternative requirements are economically and technically feasible." In February, the bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

In March, Representative John Dingell (D-MI) introduced the "Drug Safety Enhancement Act." In testimony before the House Energy and Commerce subcommittee, Congressman Dingell explained that the "legislation requires manufacturers to implement improved quality and safety standards, including stronger supply chain management." Manufacturers would be required "to list drugs by country of origin to enable us to us track movement of pharmaceuticals as they move through commerce."

PMP News has asked Congressman Dingell's whether he is proposing that FDA mandate any sort of electronic drug pedigree or track and trace system. The act does mention "a unique identifier for the establishment," but whether unique identifiers will also be required for drug items is unclear. This phrase seems to suggest "article" identifiers, too: "Drug imported or offered for import shall be refused admission unless the appropriate unique identifiers, as specified by the Secretary, are provided for such article." PMP News has asked that, "if unique identifiers are required for establishments but not for drug items, how will a given item be tracked to an establishment?"

In the meantime, both FDA and industry would be well served to examine EFPIA's pilot as well as progress made by the Global Healthcare Exchange (GHX). Rose of Johnson & Johnson noted that GHX has been "facilitating a consortium of manufacturers, wholesalers, and pharmacies to develop the requirements for the industry track & trace system."

Margot Drees, GHX's director, corporate strategy, proposed models to FDA, explaining that a "cloud based service" could be used "to observe, record, and authenticate" product movement throughout the supply chain. Both manufacturers and wholesalers could "generate and capture master data," while pharmacies could access those data.

FDA also heard from several drug companies urging the use of GS1 standards. "Talecris would like to see FDA adopt the GS1 standards that are currently utilized by the healthcare industry, providing an avenue for domestic and global harmonization," wrote David Corbett, director, regulatory compliance, for Talecris Biotherapeutics.

GS1 detailed those standards for FDA, suggesting that supply chain interoperability can be best obtained through the use of "a common business language within the framework of a comprehensive standards system."

FDA even heard from the parcel shipping industry. John David Putman from FedEx Services submitted several comments to FDA, even addressing the challenge of garnering pharmacy support. He points to FedEx's customary program to provide PCs and stand alone PC or server software for shipping. If pharmacy use of an electronic verification system were to be funded, pharma track and trace could also "dovetail nicely with EHR [Electronic Healthcare Records] for patient RX records that is also being mandated AND is being addressed by vendors. That is, the SNI could be required as BOTH part of EHR pharmacy dispensing records AND for track and trace reporting (that reporting, of course, merely NOT having the individual patient information EHR RX will)."

Clearly, building and accessing data is THE issue for the supply chain. Stakeholder collaboration and cooperation (and perhaps legislation, too) are desperately needed to determine how specific data must be as well as when data must be collected and authenticated.

Judging from the comments submitted to FDA, many drug manufacturers are preparing to handle item-level data, but, of course, there is much work left to be done. If point-of-dispense authentication is required, for instance, it would radically change the entire drug supply chain.

Daphne Allen
Editor, PMP News
daphne.allen@ubm.com

P.S. As David Vaczek reported in our last issue, California has acknowledged that a federally mandated electronic pedigree or serialization system would supersede its law, and many pharmaceutical companies are indeed awaiting further word from FDA. For now, however, California's law is the only one requiring electronic pedigrees in the United States. Pharmaceutical companies must begin now in order to have 50% of their products serialized by January 2015. Following GS1 Healthcare US's initiative will help companies work toward compliance.

Please visit www.regulations.gov to read all docket submissions. There is so much to digest, including input from the Healthcare Distribution Management Association and its members as well as other supply-chain partners!

We would love to hear your analyses, too!

While Industry Awaits Federal Mandates, GS1 Healthcare US Plans Time Line Guidance for 2015 Preparedness

GS1 Healthcare US is developing a time line or road map highlighting the milestones recommended for meeting California's pedigree law, which begins taking effect January 1, 2015. The road map will be published in the first quarter, says Bob Celeste, director, healthcare, GS1 Healthcare US.

Companies have gained insights on automatic identification and data capture (AIDC) and data-sharing requirements with partners in recent pilots, as industry moves toward development of the interoperable traceability solution required by the state.

Those participating in the GS1 Healthcare US 2015 Readiness Program are using GS1 US's Visibility Reference Model for the U.S. Pharmaceutical Industry (VRM-Rx) simulation software to model how products, information, and EPC Information Services (EPCIS) events flow through the supply chain.

"Many companies have gone through discovery processes where they have learned what takes place versus what they thought would take place. They have requested we develop a time line. We will work back from 2015 to identify the key milestones they should consider in their individual plans," Celeste says.

The compliance time line will include sign posts for development of EPCIS-based transactions in the framework of GS1's distributed pedigree system, as well as how to manage e-pedigree transactions for those companies using its Drug Pedigree Messaging Standard (DPMS), Celeste says.

"The road map will include EPCIS as part of the move toward pedigree transactions and data sharing for supply chain visibility. California and FDA are watching what we are doing and what industry is doing with EPCIS so they have a better understanding of what it is and the benefit it provides for both patient safety and supply chain security," Celeste says.

"In 2006, California clearly indicated that DPMS is acceptable for meeting the pedigree law. We have stopped short of saying EPCIS is a pedigree system that would meet the requirements of the law, because the industry hasn't had that conversation with them yet. At a certain point when industry is ready we will meet with the regulators to explicitly describe the EPCIS system and find out if they would accept this as a pedigree method or not," Celeste says.

A GS1 global group is working on enhancing EPCIS's support of pedigree events in addition to business events. The group is evaluating how security features such as digital signatures or finger printing, for example, might be used for securing an EPCIS message as it moves between trading partners and past trading partners through the chain, Celeste says.

"EPCIS is a secure messaging standard. Pedigree laws are unique in that they are the few eCommerce-like requirements where the message needs to persist, not just peer-to-peer, but all the way through the supply chain," Celeste says.

"The security mechanism [for EPCIS] needs to be both secure and nimble—a lightweight solution that accommodates fast-moving supply chain product," he says. The group is looking also at how quickly such a solution could be implemented, he adds.

A reconstituted California State Board of Pharmacy is scheduled to address the inference issue at a Board meeting in July 2011. To comply with the current law, wholesalers would have to break open every case to verify 2-D bar coded items shipped from the manufacturer.

"The Board has understood [the burden imposed on wholesalers], but they don't want case content inferred forever. They have said that you would not want two hops through the chain before the case is opened. They are asking where the real risk in the supply chain is and how long can you be assured that the items are still in the case, tote, or other container," Celeste says.

Industry piloting will accelerate significantly next year with manufacturers implementing AIDC and data sharing with partners. "The large wholesalers have gone through a couple of generations of tracking software, and smaller wholesalers are starting to plan for implementation," Celeste says.

Vendors of hardware and software have learned from pilots in developing products that are more interoperable, supporting linkage between pedigree and inventory management applications.

"Epedigree was seen early in the process as a kind of 'bolt-on' system at arm's reach from the companies' inventory management systems. Vendors are collaborating to integrate the pedigree architecture with warehouse management and other databases to enable more seamless management of serialized information," he says.

California has acknowledged that a federally mandated electronic pedigree or serialization system would supercede its law, and many pharmaceutical companies are indeed awaiting further word from FDA. For now, however, California's law is the only one requiring electronic pedigrees in the United States. Pharmaceutical companies must begin now in order to have 50% of their products serialized by January 2015. Following GS1 Healthcare US's initiative will help companies work toward compliance.

David Vaczek
Senior Editor, Pharmaceutical & Medical Packaging News
david.vaczek@ubm.com

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Serialization: It's Back On!

FDA’s just-released guidance on standardized numerical identification (SNI) for prescription drugs doesn’t set a timeline for implementation, and California’s initial electronic pedigree deadline is well over four years away.

But waiting to serialize drug packages may no longer be prudent. More standards are on the way, so the sooner your company grows adept at serializing saleable package units, the better prepared you will be for further guidance or possible rules. In addition, you’ve got some tricky moves to master, such as producing the SNI in both machine-readable and human-readable formats and capturing all this data on the packaging line. Your lessons could then be shared with FDA to help guide its future standards.

For the SNI, FDA recommends the use of a serialized National Drug Code (sNDC) consisting of the NDC and a serial number up to 20 characters long. The serial number can be numeric or alphanumeric, but it should not include an expiration date, lot, or batch code. And while the agency does not recommend a specific data carrier, it does urge coding that supports both electronic and human reading.

FDA believes that its recommended SNI will help with standards and systems development because it allows for “the unique identification of specific prescription drug packages,” explains Crystal Rice, a spokesperson for FDA’s Center for Drug Evaluation and Research (CDER). “This unique number will facilitate tracking and tracing a specific prescription drug through the supply chain in order to determine who was involved in the distribution history of the product. This would help to protect the product by providing accountability throughout the supply chain for the legitimate partners in the supply chain, and it may allow for illegitimate entities and products to be detected more easily.”

With the basic code in place, you can begin tackling the issues of adding the sNDC to your packages. You’ve got choices here, but you’ve also got existing FDA rules to satisfy. FDA “is not recommending a specific data carrier at this time,” says Rice. However, a linear bar code encoding the NDC is currently required for drugs packaged for hospitals. Given FDA’s suggested sNDC, you will have to decide whether the linear bar code will also be able accommodate the sNDC. If not, you’ll have to decide whether to add a separate bar code or whether to package drugs for hospitals differently from those packaged for retail pharmacies. Two bar codes on one package could result in confusion in the healthcare setting. FDA declined to answer whether it would change its Bar Code Rule to allow for the use of one 2-D bar code to offer a more practical bar coding solution than the mandated linear code.

RFID also remains a possibility. “The SNIs described in this guidance are compatible with, and flexible for, encoding into a variety of machine-readable forms of data carriers, such as 2-dimensional bar codes and radio-frequency identification (RFID), leaving options open as technologies for securing the supply chain continue to be identified,” FDA states in the guidance.

James Mannion, Solutions Marketing Director, and Sue Hutchinson, Director of Industry Adoption, for EPCglobal US and GS1 US, welcome such flexibility, saying that it demonstrates an appropriate focus on the data itself. “FDA is more concerned with how data are exchanged than the carrier itself,” notes Hutchinson. “FDA is concerned with the common language and a common way for supply chain partners to speak to each other.”

Adds Mannion: “You cannot have item visibility unless you speak the same language.”

You’ve also got to look at your labeling space. Even if you can just print the space-saving 2-D Data Matrix or employ RFID tags, you’ve got to accommodate more human-readable information and ensure its legibility. FDA is “not specifying a location on the package where an SNI should be place,” the guidance reads. “If the NDC is already printed on the package in human-readable form, then the serial number could be printed in human-readable form in a non-contiguous manner elsewhere on the product package.”

You have also got to equip your packaging lines with inspection systems ready to verify all printed serial codes and/or preserialized label placement or to add tunnels for reading RFID tags. You also have to be ready to track it all, even those serialized items rejected on the packaging line.

Also, FDA mentions GS1's GTIN standard in the guidance but no other system, such as that from the HIBCC. “GS1's GTIN standard was highlighted because it was one example that is compatible with the recommended serialized NDC in the guidance,” Rice states. Your company will have to decide whether to adopt GS1 standards or investigate whether other approaches can accommodate the sNDC.

FDA did not say whether it was waiting for industry to implement the SNI in order to witness real-market challenges before it issues future guidances or regulations. But Rice did explain that “many aspects of implementation of package-level identification will take shape in the future as standards that make use of the SNI are developed.”

FDA does not offer any specifics on whether its next steps will be guidance or regulation, nor does it give a specific timeline for these steps. However, “this guidance is an initial step in the development of standards and systems for identification, tracking and tracing, authentication, and validation of prescription drug packages,” explains Rice.

When asked whether FDA is waiting for further legislation, such as the rumored reintroduction of the Buyer-Matheson act, before it mandates the SNI or issues further guidance or regulations, Rice stated that “FDA would be happy to work with Congress on legislation to further strengthen the security of our nation's drugs supply.”

FDA’s SNI complies with California’s electronic pedigree law, says Virginia Herold, executive officer of the California State Board of Pharmacy. “Hopefully it will help enable serialization projects to move forward,” she says.

The state of California is eager for the federal government to take the lead. “We would like to see a national model,” says Herold. “Laws in 50 different states would make it very difficult to do business in the United States. We support federal legislation in this area, and any federal rule would take precedence over the California deadline of 2015.”

And such federal activity seems likely. While “FDA supports CA efforts to improve the supply chain,” says Rice, “FDA will continue to work on federal standards development for identification, authentication, and track and trace.”

So what will happen if you don’t implement the SNI? Today, not much. We asked FDA what would happen, but the agency declined to answer.

The long-term risks to your own operations, however, could be more serious than you think. FDA is moving ahead with its plans for further standards, and at some point, it may seek your input, either through workshops or a further draft guidance. Or it may be watching a number of pilots or simulation programs, like GS1’s 2015 Readiness Program (http://www.pmpnews.com/news/simulating-serialized-chain), for details on how to proceed with further standards and systems.

If you don’t understand item-level serialization and its challenges, you won’t be able to provide FDA with real-life information. Your company will then have little say in future standards development, and the resulting standards could be based on experiences very different from yours.

Hutchinson of EPCglobal US and GS1 US notes, “Standards development very much is like a living organism. As companies get comfortable with coding items, the healthcare products community will understand the appropriate roles of lot, batch, or serial numbers and work out the use cases. The community is taking the lead in defining the business cases. And that user community controls the pace by which we work to develop standards.” Interestingly, FDA calls itself an “active observer and participant in GS1 standards development related to healthcare and drug products.”

As a member of that community, are you preparing to evaluate SNI’s role in your own business cases?

Daphne Allen
Editor

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Over the past several months, we’ve seen a marked increase in Nosco drug & device customers turning to serialization. They are implementing solutions for many reasons and using both 2-D bar codes and RFID. Uses range from track & trace, DoD, U.S. mandate preparedness, European mandates, and their own unique process-based requirements.

Whether or not federal mandates will occur in our lifetime, it’s clear that drug safety, anti-diversion, and an on-again/off-again push for drug re-importation remain areas of heated debate. For example, at a March 10th 2010 hearing, “Drug Safety: An Update from FDA,” by the House of Representatives Committee on Energy and Commerce, Subcommittee on Health, Joshua Sharfstein, Principal Deputy Commissioner of the FDA, explained that the worldwide counterfeit market is expected to grow to $75 billion when discussing imported drug safety.

Nosco’s advice continues to be “Be prepared & start early.” Capacity of expertise and priority on pharma is limited because of many false starts. If there is anything we’ve learned (sometimes the hard way), it is that legislation has a way of surprising us. It will be stuck in low gear for years, and then, like a swat in the head, bam, it’s law!

Learn how we can help you get started. Contact Andy Tippet at atippet@nosco.com.