Keeping Counterfeit Goods Out of the Supply Chain

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

Rowe: 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.”