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Articles

States continue to push for a ‘bio-economic’ foundation

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Drugmakers recalibrate anti-counterfeiting and serialization efforts

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Building an Alternative Distribution Model for Ultra-Orphan Diseases

 interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:

The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech

An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars

How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later

Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Podcast is available directly on SoundCloud.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

Facing Potential Drug Shortages, FDA Delays Enforcement of DSCSA Compliance Deadline, with Stipulations

With the implementation of unit-level traceability, the collaboration is expected to provide additional visibility not only within the aseptic manufacturing process, but the entire supply chain overall.  

BD, ten23 health to Roll Out Prefillable Syringes with RFID Capabilities

A panel offers its perspective on bolstering the temperature monitoring and data sharing process. 

LogiPharma USA 2024: Enhancing Cold Chain Insights

With the Nov. 27 deadline fast approaching, is the pharma supply chain ready for full data exchange?

LogiPharma USA 2024: Working Toward DSCSA Compliance

The collaboration is centered around meeting track-and-trace requirements. 

Arvato Systems, Advanco Form Serialization Partnership

WEE request process

 Could you describe what the Waiver, Exception or Exemption (WEE) request process entails?

So essentially, under the statute, there are different conditions that a member of the supply chain can claim. For instance, if some requirement causes them undue economic hardship—that’s just on example—they can apply for a waiver, exception, or exemption. There are some parameters that are put out by FDA in their guidance on this, which is all available on their website. HDA is also going to have a compilation of all the guidance that the FDA has done, to put everything in one place and walk people through so that you can know what to do, such as if you need a WEE, here are the steps. Here's where to go on the FDA website.

The way that you do it on the FDA website, it's through their portal, NextGen. It looks a little daunting, but I think it's been pretty much simplified. When you're applying for a waiver, exception, or exemption, you need to really spell out why you need it, what you need it for; if there is a time period you think you're going to be ready for compliance in six months—be more narrow—and then also describing the problem, describing why you can't meet that particular requirement, essentially providing justification for why you need this exemption.

 What other sessions or topics at the Traceability Seminar are you looking forward to?

FDA speaking is always sort of the number one, and it's funny, sometimes they say new, exciting things, and sometimes they just provide reassurance or reiterate what they've put out, or clarifications. It's just a time for them to be in front of our members and the attendees of the conference, so that's always good. We also have a couple different panels this year.

For instance, we have a legal panel tomorrow afternoon with some lawyers who practice in this space, in which we’re trying to get their perspective on what they're hearing from clients. And that's always interesting, because sometimes, it uncovers different issues that—at the trade association level—we might not be aware of, and that every day trading partners might not have heard of. It's just interesting to see the perspective of different folks, along with what kinds of problems or issues companies are going to them to try and help them solve.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.  
  


Latest Conference Coverage

HDA 2024 Traceability Seminar: The WEE Request Process

Waivers, Exceptions, and Exemptions session 

 You recently spoke on a panel regarding “Filing Waivers, Exemptions, Exceptions: Lessons Learned – and other HDA Perspectives on DSCSA Implementation and Readiness.” What was discussed during the session, and what questions did the audience raise?

I did the panel—it was myself and also two of my colleagues, Tish Paul from OFW Law and Brian Waldman from ArentFox Schiff. We work together a lot on these issues, and have worked together for years. We talked about the WEE process, or waivers, exceptions, and exemptions process, just in terms of this being a tool that is written into the statute for DSCSA. It's something that's available. It's something that FDA has encouraged. We talked about the need for timely decisions about WEEs, as well as some of the complexities—even if a WEE is granted, there are also additional complexities with managing those, so in addition to the WEE process, WEEs themselves, and where FDA is on all of that, we talked a little bit about HDA’s positioning right now, given our members’ focus on implementation and what we're seeing in the industry, just at least in the distribution sector, which really does provide us with an eagle's eye view, both upstream and downstream.

That’s kind of unique. We really just wanted to share with the audience what we're experiencing. Then, we conducted some Q&A, where we got some good questions about some very technical things that folks are grappling with, such as transition or grandfathered product, SOPs, or what a pharmacy do when they have a patient in front of them and no data with their product transactions. It was pretty diverse in terms of the topic or subject matter. We originally started out doing just what we had planned—the WEEs—and then, as we got closer and closer to the date for the presentation, realized there was just so much going on right now.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

HDA 2024 Traceability Seminar: Filing Waivers, Exceptions, and Exemptions

pharma DSCSA compliance

 Following FDA’s implementation of the stabilization period last year, what is the pharma supply chain's overall preparedness in adhering to DSCSA’s Nov. 27, 2024 compliance deadline?

We're in a good place. It's not ready 100%, but FDA is implementing this one-year stabilization period, which allowed the supply chain to mature, and the connections really helped. We're at a much better place than we were last year, and we're closer to really being where we need to be, but there are still connections between trading partners where the data quality is poor, where there's discrepancies in information that's provided, and those need to be cleaned up. If there's a discrepancy or you don't have data, but you have product, that product can't move to the next trading partner, so a wholesaler can't sell it to a dispenser, and that means that product may not get to the patient who is waiting for it in the pharmacy.

All of these little end bits of data quality and making sure that your systems and processes are working and interoperable—that all has to be fixed and cleaned up. If you don't have that, if you're not ready, or your trading partner isn't ready, you got to go back and get that exemption, or WEE, that I talked about earlier.

 Although not required per the DSCSA, what have you heard in terms of companies tagging their products with RFID labels?

 Ten years ago—or even 15 years ago, we thought RFID was the next wave of making sure that you know where the product is, but we're not there. In fact, the DSCSA requires that two-dimensional barcode, and that takes enough real estate on the label and the package, that's where all of the focus is. Some companies are using RFID to help identify where a product is within their four walls, but it's not being used—as far as I know—for that tracking and tracing of a product through the supply chain. It's all focused on the two-dimensional barcode.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption. 

HDA 2024 Traceability Seminar: How Prepared Is Pharma for DSCSA Compliance?

best practices stabilization period 

 As the end of the stabilization period approaches, what best practices should compliance teams consider?

It depends on whose shoes you're standing in. If you're a dispenser, you should know where your data is being held, because sometimes the wholesaler is holding the data. Sometimes you may have a solution provider, so that goes back to the SOPs and making sure that your employees know where they can get the data if they need to, and that they know how to verify the product identifier, because now, starting in November, for most cases, the product identifier will be on the package and available to be able to verify with the manufacturer if it's the accurate and the correct product identifier.

They should have been able to do that before, and they were able to do it before, but now, the product identifier will be on the transaction documentation that's traveling with the product. Having those relationships with your trading partners [is important] because it's all about who you're doing business with, in order to have that confidence in the transaction and knowing that you're getting legitimate product.

That actually goes back to another best practice, which is making sure that you have the systems and processes in place to identify suspect and illegitimate product, along with what to do if you find it. The supply chain should have been doing this since 2015, but now this is more important than ever, as now the whole supply chain has moved on, and DSCSA has matured.

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November. 

HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period

DSCSA legal advice 

 You have an upcoming panel on “Legal Perspectives for DSCSA Compliance Teams.” What hard-hitting points will be discussed during the session?

It's a panel of four lawyers in a room full of supply chain experts. We've identified a couple of different issues and really want to get at it at a very high level for them [compliance teams]. The first and foremost issue is how important it is that if you or your supply chain trading partner are not ready, that you should be applying for a WEE. A WEE is a Waiver, Exception, or Exemption, and for the most part, trading partners should be applying for an exemption if they know that there may be some problems in moving the data, receiving data, or transferring the data to their trading partner. It may be that they're ready, but their trading partners aren't. This also includes how important it is to get a WE, which is something that you apply to FDA for, you explain why you need an exemption from certain requirements of DSCSA in order to be able to keep drug moving through the supply chain because it's all about making sure the drug gets continues through the supply chain to the patients when they need it.

Another area that we're going to be focusing on is how important it is to have SOPs, standard operating procedures. This is a no brainer because most of these companies should have SOPs in place, but the law requires you to have systems and processes, and that's all about having those processes in place, having them written down, training your employees on them, making sure that they follow those SOPs, and then training them again. That's a really important aspect of why that is important, because when FDA or a state investigator comes in, they're going to ask and look at what you are doing, and you can show them your SOPs, which are documented of how you are complying with the law.

Another aspect that we're going to be talking about is there was a Supreme Court case that came down earlier this year that impacts a lot of what FDA does, and it could impact parts of DSCSA. For example, what the case did is it changed the standard that courts will look at when they're evaluating whether or not FDA has interpreted a law correctly. If the law doesn't spell out how FDA has to implement it, previously, FDA would take a reasonable, rational approach. What this new court case says is it's up to the courts to determine if the law was interpreted correctly, and so how does that impact the DSCSA? It could impact wholesale distributor licensure rules that are in preparation right now. A proposed rule was published two years ago, and FDA will be finalizing it soon. What this means is FDA is going to look really carefully to make sure that they get it right, because they don't want a court to second guess them, and so that we're going to talk a little bit about that as well.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar. 

HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Michael Rowe counterfeit product

What else should be done to limit “bad actors” from attempting to bypass the FDA by sneaking counterfeit drugs into the supply chain?

The DSCSA is not the one and only way to keep counterfeit product out from the supply chain. I think the FDA even hit on this. Having trusted trading partners that you're doing business with is critical, and no law is going to circumvent that type of due diligence that when you're purchasing pharmaceuticals, making sure that you're doing it from reputable sources. If a deal seems too good to be true, it probably is. I think trading partner trust is critical. I think we're also seeing a proliferation of bad actors almost circumventing the actual supply chain and going direct to consumers, and so that's also important to keep in mind—that there needs to be broad, actual awareness to patients that you need a valid prescription and you need to go to a valid pharmacy to get a prescription medicine; going to Facebook marketplace to purchase prescription drugs not a good place to go.

I think a lot of education still needs to happen. If we think about it, manufacturers and wholesalers play a huge role in keeping the supply chain safe, but really, the pharmacies are at the end of the line, and really need to be fully aware of their DSCSA obligations. They're there to help pharmacies screen bad product, and so making sure that when you're receiving product in that you're doing the right data checks, you are looking at the seals, looking at how the product is labeled, if anything is suspicious, raise that. I think our pharmacies—they're very busy and have a lot of competing priorities—but I think that's an area that could use some more bolstering. And I think that’s where the FDA and other stakeholders can come in and educate pharmacies.

The other area that is a challenge is duplicate serial numbers. The law requires that each product has its own unique serial number on there, so if a number has a duplicate on there, that obviously is a warning sign. I think what is difficult is that our supply chain isn't just linear; in terms of this serial number, it goes from A to B to C, sometimes it goes to A to B, then it goes back. There's these returns, or products are moving, so it doesn’t necessarily require that that serial number -be seen again. I think that's where we must determine, how as an industry, do we flag a duplicate serial number better in a way that also doesn't prohibit things like returns and products that are coming back and going back out that's still good.

I think the industry is still thinking about how to get through duplicate serial numbers as another area to help bad actors. I think the other is, what the industry is still sorting through, in my mind, trading partner credentialing. Under the DSCSA, everyone has to be properly licensed to sell or distribute pharmaceuticals. But we've seen instances where people fake these credentials. They fake that they have a license from whatever state to distribute this. I think more work using technology to credential these trading partners—in order to prove that they're authentic, that they have a valid license, and that these aren't made up—is another area of importance as well.

There's been a lot of great pilot work and groups that have done that. I feel like they've not gained a lot of momentum, just because we're still trying to do the basics of blocking and tackling, of sending good data on time, and it's hard to then build a use case on well, “I need to invest more technology or processes around credentialing licenses when I can't even send data and move the product.”

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.

Keeping Counterfeit Goods Out of the Supply Chain

Michael Rowe Stabilization Period

Do you believe there is any chance of the FDA extending the stabilization period beyond Nov. 27

If history repeats itself, there's been some sort of delay in enforcement pretty much for every major deadline up until now. Now, I will say that you are correct. The FDA has recognized that small dispensers or pharmacies need more time to get ready, and it was announced right before the public meeting—and then was reinforced at the public meeting—that any pharmacies with 25 or fewer pharmacy and pharmacists on staff, would have another extension of the stabilization period, another two years. So actually, Nov. 27, 2026 for those smaller pharmacies. I think primarily pointed at independently owned pharmacies, was really the goal there. So the FDA has extended it, but only for those entities that qualify.

What FDA has stated is that any other type of trading partner—manufacturer, wholesaler, a larger dispenser—regarding the stabilization period, they're very adamant that it is not going to be extended in a broad fashion. What the FDA was really posing at the meeting and in their updated guidance was that they're not going to offer broad enforcement discretion, but if you as a specific trading partner don't feel that you can comply with the requirements after Nov. 27, you could file an individual waiver exemption or exception—fondly called a WEE—so the FDA is saying, we're not going to give a broad delay, but you, as an individual trading partner, can get one, but it's up to FDA’s review.

A lot of the public meeting was spent on how feasible is that, how many companies will apply. There are many companies now that maybe weren't thinking about filing for a waiver and exemption that are now. I think that's the stance from the FDA. I'll put on my Michael Rowe hat here—one of the recommendations that I made at the public meeting was that there still needs to be another relief valve beyond a trading partner-specific relief valve. And what I mean by that is, we have a customer that sends data, and then their customer goes, “Hey, you sent me the wrong data. Can you fix it?” It's those types of errors where the product is still good, and if a risk-based analysis is done to prove that it's not a suspect drug, can we at least let that product move so a patient doesn’t get impacted at the end of the day? I think that's the big worry. It’s not that there are companies simply not passing data, but it's when there's a problem with the data. we can't quickly fix it right now. So one of the recommendations that I hope FDA takes into consideration is almost a threshold risk-based approach that says, “as long as there's these other measures that are done to verify that the product is authentic, can we let the product go through, even though maybe the data isn't with that product.”

We obviously have to limit that. We can't make it super broad, because that could impact patient safety. If there's a blanket bypass allowed, that could potentially, like counterfeiters, go in and say, “Oh well, I'm operating under this bypass threshold allowance,” so it's got to be balanced, but I fear that if we even move the needle another 10%, that could make roughly a quarter of all medicines in the US quarantined at any given day.

There's not that much safety stock in the supply chain, and you now have a pharmacy that has a patient there trying to get the medicine, and they're saying, “I can't order the product because it's stuck at a wholesaler in quarantine because there's bad data on it.” It's going to be a hard—maybe pun, not intended—pill to swallow, to say, well, this is actually authentic product, but I can't give it to you because I can't validate the serial number.

So I think it's going to be a difficult position for a lot of companies to be in. I don't think FDA will give another broad enforcement delay like they have in years past, where they say everybody gets another year. It's going to be very controlled, very measured.

It was actually quite funny at the FDA public meeting, they did one of those word doodles, where people type in their response and they said, “what do you think FDA should do, or what do you what do you think about the stabilization period, and what should happen next?” As more people type in the same word, the bigger it gets on the screen. So all of a sudden, everyone starts saying, “enforce DSCSA, do not delay.” That becomes the biggest thing on the board, and then this other word stops coming up, “delay, delay, delay, delay.” So now up on the screen, you have two words that are in complete polar opposite of one another. I'm in the camp of another broad delay is not going to be beneficial to the industry.

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, predicts the likelihood of stabilization period postponement. 

Extending the Stabilization Period

DSCSA Implementation and Stabilization Efforts

 Back in June, the Partnership for DSCSA Governance (PDG) and the FDA held a joint public meeting on DSCSA implementation and stabilization efforts which you attended and spoke at. What exactly was the purpose of the meeting, and what was accomplished?

Back in middle of June, there was a public meeting that was facilitated by FDA in partnership with the PDG which is the Partnership for DSCSA Governance, which is a group that's really working collaboratively to work on standards on how to comply with DSCSA. The FDA is actually a sitting member within that committee. The purpose and intent behind the meeting was really to act as a listening session, almost like a check in on how things had progressed from the stabilization period announcement back in August of last year—how well had industry moved to enhanced drug security—and so it gave an opportunity for different stakeholders to provide their perspectives, to share what's going well, share what's not going well. That was really the main intent. It was a listening session, primarily, and that was its intent, and was that accomplished? I think we'll have to see how the FDA responds after being at that meeting. It was also an opportunity for the FDA to share a little bit about their perspectives, and they made it very clear at that meeting that the stabilization period will not be extended in a broad manner.

Despite some of the challenges that a lot of industry players have, I think a lot of progress has been made, but there're still a lot of concerns about what I call these clerical exception-based errors causing product that really is good, but keeping that from further being distributed. At the same token, regarding balancing patient safety for medications that really shouldn't be in supply chain: how do we curb that?

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.

Complying with the DSCSA

Michael Rowe Serialized Data

 What is the current state of affairs of DSCSA?

In order to set the context for where things are today, you have to look back over the past couple years of where we've been. The DSCSA has these series of milestones. In 2015, the industry went to lot level tracing, where we were tracking quantities and lots, and how those products were being moved through the supply chain. In 2017 and 2018 is when products started to become serialized by the manufacturer. A lot of packaging changes were happening, and the manufacturers were storing a lot of data, but that data really wasn't leaving or moving with the product.

Since 2018/2019, the industry has been working toward getting through fully interoperable data exchange. The enhanced distribution requirements—as laid out in the law—were set to kick in in Nov. 27, 2023. Up until this time, almost last year, the industry really was sharing that the amount of data that was supposed to be flowing with the product was not where it needed to be. The FDA introduced this “stabilization period,” this one additional year for companies to continue to improve the ability to transmit the serialized data with the product. I like to say that there's a breadcrumb of serialized data that moves with the product as it moves, as it changes hands, and as a way for companies to have their own database to use in a suspect drug investigation to help identify counterfeits. That’s the background of where we are and where we got to.

The current state of affairs is the amount of data that's being moved and the amount of connections that are happening has really improved significantly over this time last year, where the industry at whole was reporting that maybe they were getting 20% of all of the products coming with good data. Right now, wholesalers are generally reporting that it's in that 70% range of where we've moved the needle about another 50%, so that's really where we are today in terms of data exchange, and that's been improving.

 Where do you see opportunities for improvement?

Where I see the opportunities for improvement and where things are still needing to improve is around what I call exception handling. This is a big buzzword in the industry right now.

What happens if product arrives but there's no data? What happens when the file is late and the product shows up before the file? While there's been a lot of good work theorizing on how to solve those exceptions, there are types of exception scenarios—including the ability to test and pilot in order figure out how to fix those issues and build those standard operating procedures— that aren’t really where they need to be in the industry.

I'll give you an example with a client of ours. There was a file that was inadvertently transmitted, so wrong serial numbers were sent to their customer. We spent months trying to figure out, how do you correct a file that's already been sent out? It's those types of interoperable data challenges that the industry really is still not prepared to handle.

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the Drug Supply Chain Security Act, along with opportunities for improvement. 

A Breadcrumb of Serialized Data

Michael Rowe DSCSA

 Could you provide a brief overview of the Drug Supply Chain Security Act (DSCSA)?

The DSCSA, which stands for the Drug Supply Chain Security Act, is a federal law that was passed by Congress in November of 2013 and within the law, there were a series of milestones that established a federal universal standard around track and trace of prescription pharmaceuticals in the United States. The reason the law partly came to be was prior to the law being in place, there were a series of patchwork of states that were passing different laws around the regulation of pharmaceuticals, and how they're being distributed and tracked and traced.

Mainly, in 2008, you had the California track-and-trace regulations and Florida pedigree requirements. The industry came together to say a patchwork of 50 different laws to try to comply with different packaging requirements would really not be feasible. Thus, the DSCSA was born. Within that law, there were a series of milestones around developing and getting to what's called unit level traceability through serialization. Some people call this the serialization law, as a result of it changing how manufacturers needed to package the product, but more importantly, it came with a lot of other provisions around data exchange, around the ability for the industry to quickly verify the serialization data, and around requirements for licensing for 3PLs [third-party logistics providers] and wholesalers in the United States. While many people call it the serialization law and think it's just about putting a serial number on a package, it's really much more complex than that, where it has a lot of different requirements on all different trading partners within the industry.

One thing the DSCSA also did is identify and define different types of trading partners, such as the difference between a pharmacy called a dispenser, a manufacturer, etc. It really did, in some cases, revolutionize but also standardize how the industry should be approaching security of pharmaceuticals, and the intent of the law at the end of the day is to curb counterfeit products from entering the legitimate supply chain. That's really the ultimate goal and what the DSCSA is all about.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, offers a brief overview of the Drug Supply Chain Security Act. 

Security

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