COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the launch journey.

Today, we spoke with DSCSA and Serialization Services Manager Michael Rowe about the effect of COVID-19 on the DSCSA regulatory timeline.

How is COVID-19 impacting DSCSA?

In short, it isn’t. While the FDA may temporarily be tied up in other work and may pause on site verification visits, manufacturers should still count on having to report as usual.

Impact is minimal. The FDA is issuing a pause for certain DSCSA requirements ONLY for manufacturers who are working on drugs that are essential to addressing the COVID-19 pandemic. Loosening these requirements for drugs directly tied to the public health emergency allows for easier distribution without the same rigor of record keeping for drugs that are bought and sold under DSCSA. For the majority of clients that we work with – as well as the majority of pharma manufacturers overall – the DSCSA is in full effect and enforced for manufacturers. Even though the FDA isn’t operating as normal right now, they could retroactively ask for the required documentation.

How is COVID-19 Impacting the Wholesaler Saleable Returns Requirement?

Another FDA extension is unknown and unlikely. After already issuing one delay on the saleable returns deadline, there still remains many challenges for manufacturers and wholesalers even without the impact that COVID-19 is having on their operations. The Pharmaceutical Distribution Security Alliance (PDSA) plans to send a letter to the FDA supporting other requests from trade associations asking for a delay and a soft launch period. Getting the FDAs attention right now will prove to be very difficult. Another extension past Nov. 27 is unlikely but we will continue to monitor those changes.

Stay the course. The advice we’re giving to every client is to carry on with business as usual; stay the course and make sure you’re preparing to meet the Nov. 27th deadline. Even if the FDA postpones the requirement, it will still happen eventually, and proof of progress needs to be visible.

The wholesalers are also making requests to onboard earlier than November. And for pharma manufacturers who are still in the early stages of their plan and looking at a launch date 1-2 years out, this is still a regulatory requirement, and they will not be able to go to market without meeting it.

How should pharma manufacturers approach DSCSA right now?

Be diligent about your partners. It’s always important to select the right partners, and COVID-19 is proving that. The current crisis is showing fault lines in processes that were previously thought to be reliable. Every manufacturer should evaluate their (potential) partners and consider how they are handling the crisis at hand.

Think long-term strategy. Although cutting corners to save costs might provide cashflow relief now, it’s better to have partners involved earlier rather than later so that you don’t overpay down the road by either hiring too many partners or trying to cobble together internal resources that weren’t meant to address the project at hand. A partner like Two Labs can help you craft the right strategy up front so that you make the right investment decisions in accordance with your goals, budget and timeline.

Do you need help determining the impact of COVID-19 on your launch and how to navigate
forward? Click the button below to get in touch with our expert team.