by Michael D. Sarlo, EnCE, RCA, CBE, CCLO, CCPA
Starting this Friday, May 5th, the U.S. Food and Drug Administration will only accept New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) in the Electronic Common Technical Document (eCTD) format. One year from that date, or May 5th, 2018, the eCTD submission guidelines will also apply to Commercial Investigational New Drug Applications (INDs) and Master Files.
The implications of this legislative overhaul are relatively vast, and while the impacts on pharmaceutical companies and medical innovation at large are obvious, they are not the only ones. Rather, this is a major development in the forensics and eDiscovery realm.
I fear that many entities who will be impacted are still not prepared for the sheer magnitude of the eCTD submission guidelines. Let’s take a deeper look at this.
What’s the trouble?
Flashback about 10 to 15 years, and most pharmaceutical and medical-related organizations were entirely paper-based. In fact, the standardization of electronic records in the health field at large really did not come into play in the United States until the Health Information Technology for Economic and Clinical Health Act passed in 2009. That legislation really only covered health care providers, forcing them to achieve meaningful use of electronic health records.
The FDA quickly followed suit, though, working to standardize and digitize the processes of pharmaceutical companies and medical device manufacturers. Paper records were the undesirable standard for tracking development of drugs and other medical products, and regulators realized that this was simply not up to snuff with modern standards.
Now, this week marks the first big deadline with respect to the eCTD format demands. On one hand, this is a very necessary overhaul of workflows and record keeping procedures both for the organizations the legislation covers and the nation’s regulatory apparatus. On the other, it is a massive disruption to the status quo that requires a tremendous amount of work to maintain compliance.
The disruption that covered entities face, though, do not hold a candle to the proverbial nightmare attorneys and other entities responsible for review are now going to confront in litigation proceedings and risk management practices. Because eCTD files cover virtually every single change, manipulation, and action a given application and record has gone through, the review implications are heavy to say the least.
Attorneys who have worked in these industries know how fierce the FDA is with respect to its regulations, standards, and enforcement. Now, tack on this complex overhaul of application standards and it becomes clear that the true challenge will be establishing a new method to govern, manage, and monitor eCTD in such a way that is conducive to eDiscovery and digital forensics.
eCTD through the eDiscovery lens
Whether it was because of procrastination or a complete lack of awareness we may never know, but the eDiscovery industry – and likely the legal entities that rely on digital forensics services – were simply not prepared. One thing is abundantly clear, though – now is the time to get prepared.
The eDiscovery process will be impossible in the realm of eCTD should attorneys not have access to a specialized solution. Between the complexity of the processes surrounding eCTDs and the sheer volume of relevant communications related to each one, attorneys would simply not be able to review these files efficiently nor really have a shot at identifying the information they need in a litigation proceeding using existing techniques and tools. In all honesty, I would have to argue that it would be completely impossible.
This dilemma applies to both the front and back end perspectives – from preparedness to responsiveness and everything in between. What you have is this entirely new segment – and a big one – of the eDiscovery marketplace that is entirely driven by user experience, yet not close to being entirely mature. To be clear, eCTD submissions represent incredibly valuable and sensitive intellectual property.
As all attorneys who work with intellectual property know, the speed, efficiency, and accuracy with which eDiscovery processes are carried out can completely make or break a case. That is why all legal entities need to proactively prepare themselves for eCTD-related litigation proceedings. Additionally, in-house counsel ought to be taking an eDiscovery-focused approach to managing eCTD workflows on a daily basis.
Considering how much litigation takes place in this arena, and the speed with which attorneys need to be able to review and scan the contents of these applications in a defensible manner, the time is now to find the right solution.
Quelling the concerns
As necessity is the mother of invention, HAYSTACKID has developed a proprietary tool that acts as an eCTD module to enable eDiscovery processes in standard review workflows despite the complexity of these files. Additionally, the module can be extremely helpful for the developers and other individuals involved in the creation of eCTD long before any type of litigation proceeding takes place.
If you would like to learn more about the eCTD dilemma eDiscovery is facing today, or the specifics of our proprietary tool, check out parts one and two of the Q&A I participated in on the subject. Good luck with the deadline and remember, we have your back when you run into the litigation and discovery implications of eCTD.
Michael Sarlo is HAYSTACKID’s Vice President of eDiscovery & Digital Forensics