Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a cause of concern.
In today’s post, we will look at COVID-19 and its impact on the DSCSA: from the FDA loosening some of the guidelines to the different areas of the DSCSA that are being impacted the most. If we can understand the relationship between these two, we can have a better grasp of realistic understandings and the best course of action moving forward.
The DSCSA preparation had caused many pharmaceutical companies from all stops along the supply chain to begin working together and create plans.
Furthermore, to accomplish the lofty requirements set out by the DSCSA, the pharma industry has to work in close communication with the FDA for almost every leg of the journey. According the the FDA’s website, the close relationship will “enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities to report licensure and other information to FDA annually.”
That said, while the pharmaceutical industry’s primary focus, at least in terms of regulation, is getting prepared for the DSCSA Phase II expectations, the FDA has a lot of irons in the fire that have needed extra tending because of the COVID-19 pandemic, which we will explore shortly.
The Impact of COVID-19: An Overview
COVID-19 has dramatically demanded the attention of the FDA to other areas outside of the DSCSA, such as schools and their cancelation or evolving delivery systems. On top of that, both the FDA and pharma industry saw large numbers of employees that worked remotely during the initial onset of the pandemic, which can present many distractions and pressures of its own, as many of us know first-hand.
Because of this, the FDA showed some flexibility in dealing with pharma and the DSCSA expectations, and many of these expectations came from a 9-page document entitled “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that was released in April of 2020.
The document begins by explaining that the FDA released the exemptions and exclusions because of a belief that the prior public participation for the guidance “was not feasible or appropriate”–openly acknowledging the difficulties of COVID-19 and its impact on DSCSA.
Next, the FDA states that “Under the DSCSA, specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”
While the guidance thoroughly outlines the new expectations and the adjustments the FDA is making, it is no light read. …But don’t worry, we’ll summarize everything you need to know.
DSCSA Exemptions from the Supply Chain Security Requirements
The Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency declare certain product distribution activities to be omitted, or at least temporarily, from what is considered a DSCSA transaction. The effect of this is trading partners are no longer had to exchange translation data and the product does not require serialization, as the first phase of the DSCSA enforced. That said, many of the first requirements were kept in place, such as the requirement to conduct business exclusively with authorized trading partners and maintaining or implementing a system to investigate products suspected of being illegitimate. Additionally, the DSCSA requirements related to “wholesale distribution” no longer are included as distribution activities related to the COVID-19 pandemic.
Exemption and Exclusion from Certain Requirements
Products subject to an EUA or that are approved for COVID-19, and products directly impacted by the COVID-19 emergency and that meet emergency medical needs (e.g., treatment of symptoms) are exempt from the DSCSA tracing and product identification requirements.
Wholesalers are also exempt from all DSCSA requirements with respect to such products only. Important for Wholesalers to remember, these exemptions are limited and do not apply to other products. Additionally, even if subject to the above exemptions, FDA expects that all companies maintain supply-chain security and continue to comply with the DSCSA to the full extent. The FDA makes the point that some companies may try to profit from the COVID-19 pandemic by selling unproven and illegally marketed drugs with false COVID-19 claims. The FDA encourages companies to engage in transactions with trusted and appropriately licensed/registered companies.
As explained by Tish Paul, Principal at Olsson Frank Weeda Terman Matz PC, the nine-page guidance also outlined which products were included in the exception and which were not.
The products that were covered included those under an emergency use authorization (EUA), which means they were products that the FDA either approved for COVID-19 prevention or treatment or expected might be used in the treatment and prevention.
More products that were covered included those that’s distribution was affected by the COVID-19 public health emergency.
Also, the guidance covered the transactions of products that were used for COVID-19 care moving from dispenser-to-dispenser.
As such, the FDA says “the product tracing and product identification requirements triggered by a transaction do not apply to the distribution of covered COVID-19 products. FDA stresses that trading partners distributing product for purposes unrelated to COVID-19 ‘must comply with all applicable DSCSA requirements,’ and that the exemption does not affect requirements that are not triggered by a transaction.”
Furthermore, the April 2020 guidance affected the distributions from the national stockpile. The products in the stockpile are for the treatment of COVID-19, so like the rest of the COVID-19 products, their transactions are exempt from the requirements of DSCSA while their sale is not “wholesale distribution.”
Two particular products of note are chloroquine phosphate and hydroxychloroquine sulfates, which had a EUA issued on Mar. 28, 2020. Because of the EUA, patients who could not participate in the clinical trial could still become available via the strategic stockpile. To keep track of the distribution of these drugs under its direction, the strategic stockpile was tasked with maintaining its own distribution records that included lot numbers, quantity, receiving site, and receipt date.
The COVID-19 Impact on the FDA and DSCSA
Considering the joint nature of the relationship between pharma and the FDA, the exceptions only make sense given the way the pandemic shifted the FDA’s attention onto more pressing–or life-threatening, even–matters than enforcing the new expectations with the DSCSA or preparing for a second phase.
For a better understanding of how the FDA has been impacted by COVID-19, we will once again turn to Tish Paul, who explained how thin-spread the FDA had become and the certain areas that were affected the most. As we all know, the pandemic made it much more difficult to accomplish normal tasks, so that, in combination with all the extra duties.
As taken from Paul, here are the areas that have been affected by COVID-19 the most.
Inspections: Unless they were “mission-critical,” the FDA postponed domestic inspections. For the sake of DSCSA, this means DSCSA-related audits and inspections are not taking place unless they’re directly related to COVID-19 or another “mission-critical” cause.
Deadlines: Because of the effort being diverted to the pandemic, deadlines will be pushed back for DSCSA and more enforcement discretion.
Licensing standards: No licensing standards for wholesale distributors and 3PLS were issued by the FDA.
Reporting of theft: While the FDA was supposed to push out more comprehensive guidance on how to deal with theft, the timetable became much more open-ended and it is unlikely any such guidance will arrive anytime soon.
Guidance on serial number exchange: The FDA is considering how serial numbers should be exchanged after Nov. 27, 2023, “including specific file formats such as EDI, EPCIS or XML.” While EPCIS seems like the most likely solution, it also has a number of data exchange issues, which we covered in a post you can read right here.
During the 2020 statement, Paul also offered her advice for the best way to move forward in the COVID-19 affected world. She said, “Do document what you’re doing if it departs from the DSCSA, because it’s entirely likely that in two years an inspector will come back and say, ‘Hey, why don’t you have transaction data for these transactions?’ And the response is, ‘Well, it was part of coronavirus and memories are short.’ If you’re departing from your normal compliant practices, be certain to document that.”
The Industry will move forward.
Also keep in mind. Regardless of what enforceable mandate the FDA might overlook, the industry will not. 2023 is right around the corner. Big Pharma is already performing VRS related interaction with trading partners. The industry is also preparing for an interoperable system and they will expect that you do the same. Lot’s of time, money, and effort has been put in place to have a fully automated serialized supply chain. This effort will not be ignored, so plan accordingly.
A State of Limbo: 2021 and Beyond
While the calendar has finally changed, a lot of the uncertainty has carried over to the new year. Most industries are still looking to recover from the pandemic, and normalcy is a moving target that changes every day.
The same can be said for pharma. The big-picture summary is that the pharmaceutical industry is working on updating technology and gearing up for DSCSA Phase II to come into effect in November 2023, but there is still uncertainty regarding what specifics: what should the next move be, how do all members of the supply chain best communicate together, and will there be any delays or changes to the plan.
As of right now, we are in a waiting game. While the industry is doing general prep-work, nothing more concrete can happen until the FDA takes the lead and begins offering more solid direction or sends out more communication. Since around May of 2020, there have not been any major updates or changes to the FDA’s addressing on the DSCSA, but as soon as the Agency can extinguish all the other fires associated with COVID-19 and share more info, it is safe to say that no major progress will be made toward DSCSA.
Until then, the best thing you can do is educate yourself on the expectations and stay informed on any and every change that might come. This way, when something does change through the FDA, you’ll be prepared to act, adjust, and move forward with less friction.
About the Author: Christian Souza is the Co-Founder of TrackTraceRx