FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA). I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”). The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.
Here’s the backstory. Section 582[a] of the DSCSA requires the FDA to publish guidance by November 27, 2015 that establishes a process for members of the supply chain to apply for waivers, exceptions and exemptions to individual sections of the DSCSA. For whatever reason, the FDA has not published that guidance yet (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”, “In Absence Of FDA Guidance, Follow PDSA Recommendations”).
The problem is, sub-paragraph C of that Section says:
“(C) PROCESS.—In issuing the guidance under this paragraph, the Secretary shall provide an effective date that is not later than 180 days prior to the date on which manufacturers are required to affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce consistent with this section.”
As I said in Monday’s essay, this clause requires the FDA to allow members of the supply chain at least six months prior to the November 27, 2017 serialization deadline to apply for waivers, exceptions and exemptions (which is May 31). That makes sense, because, if you’re going to allow waivers, exceptions and exemptions, you need to have a cut-off date that provides enough time for the FDA to evaluate the application, respond to the applicant, and then, if the application is denied, enough time for the applicant to get into compliance. The problem is, if they don’t publish that guidance by that deadline, how can companies who need a waiver, exception or exemption, get one?
So I asked Dr. Jung that question in the Q&A session after her presentation. In her response, she advised companies who need a waiver, exception or exemption to simply send an email to the FDA’s email@example.com email address.
I also asked, “Shouldn’t the FDA delay the entire DSCSA timeline for the same length of time those guidances have been delayed, which is now approaching 18 months?” In her response she said that the FDA continues to work diligently on all of the guidance documents and they are trying to get them out as soon as they can.
After her session, Dr. Jung was kindly willing to let me as asked her some additional questions, one-on-one. We looked up the section of the DSCSA I quoted above because she was not familiar with that specific deadline. She said she would review it with her team and review the FDA’s official interpretation. She wasn’t able to provide the FDA’s interpretation at that time, which is not a surprise. I suggested that the Agency should, at the very least, make an announcement that they would continue to accept applications via email after the May 31 deadline stated in the law, but in my view, when they miss this deadline, they ought to delay the November 27, 2017 deadline. Dr. Jung could not comment on my suggestions.
So, the advice Dr. Jung provided was to send your request for a waiver, exception or exemption to their email address and they will get back to you. I asked what information the FDA would need in order to properly evaluate the requests and how long the process would take? She could not answer those questions, which, again, is not a surprise because these are things that would be spelled out in the missing guidance.
It appears to me that the FDA has wrongly interpreted this May 31 deadline and is treating it as a deadline as inconsequential as their original November 27, 2015 deadline for publishing the guidance documents. But this deadline is different. Without the minimum amount of time that Congress expected companies to have to apply for waivers, exceptions and exemptions, the DSCSA must be delayed. And the delay should not be just that minimum. Because the industry has not had the benefit of the four overdue guidance documents over the last 18 months, publishing the guidance documents now, without delaying the serialization deadline would impose an undue burden on the industry. In my view, the FDA should delay the entire DSCSA timeline for the same length of time those guidances have been delayed.
That said, the only interpretation of the DSCSA that matters, is the one the FDA makes. See my disclaimer on my previous essay.