HDA 2024 Traceability Seminar: The WEE Request Process
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.
PC: Could you describe what the Waiver, Exception or Exemption (WEE) request process entails?
Gallenagh: 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.
PC: What other sessions or topics at the Traceability Seminar are you looking forward to?
Gallenagh: 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.
