Legal experts note confusion about DSCSA waivers, exceptions, and exemptions

Attorneys said one of the top concerns cited by clients are the timing of submitting waiver, exception, and exemption requests (WEE) as well as some general confusion on what constitutes a WEE request under the Drug Supply Chain Security Act during a recent webinar sponsored by the Healthcare Distribution Alliance (HDA).

DSCSA mandates that after 27 November 2024, serialized data will need to be affixed onto all prescription drug packages before sending on to trading partners. Yet there is a loophole for supply chain partners who will not be able to comply with DSCSA by the deadline: FDA published in July 2023 a final guidance on its process for granting or denying WEE requests under DSCSA. (RELATED: FDA finalizes guidance on DSCSA waiver, exceptions and exemptions. Regulatory Focus, 7 August 2023)

When asked to address clients’ biggest concerns, Brian Waldman, managing partner with ArentFox Schiff, said that one the most frequently asked question with the last month is "is it too late to submit a WEE request?” He said that many of his clients are under the impression that these requests had to be submitted by 1 August.

Waldman said that while FDA recommends submitting a waiver request by August, this was not a mandatory date, and trading partners can submit a waiver request at any time. Yet he advised meaning to submit these requests “sooner rather than later.”

Ilisa Bernstein, president of consulting firm Bernstein Rx Solutions, who previously headed the DSCSA program at FDA, noted there is some uncertainty around the terms waivers, exceptions, and exemptions. “One thing though that people are often confused by is what do you apply for? What is a WEE? What is the W, what is the E?” she asked.

DSCSA specifies that authorized trading partners (ATPs) can request waivers if they would cause undue economic hardship or for emergency medical reason, or they can request exceptions from product identifiers if a product is packaged in a container that is too small; or can request an exemption if for certain public health reasons. Bernstein expects a majority of the requests to fall into the exemption category.

Yet Waldman sought to dispel a common misperception about WEEs; he said that trading partners should not view the WEE as a “get out of jail free card” and should “not be used as a last resort for you.” If granted by FDA, companies need to get their internal affairs in order.

Elizabeth Gallenagh, general counsel and senior vice president of supply chain integrity for HDA said the top concern she is hearing from distributors is they are “worried about not receiving complete and accurate data at the serial level from suppliers and being faced with decisions about the product. Distributors cannot purchase product unless they receive the requisite data, that is the biggest concern from a baseline perspective.”

Preparing for November

The panelists were also guardedly optimistic when asked to describe what will happen on 27 November, when DSCSA systems go live.

Bernstein said that “everyone thought the sky would fall when Y2K hit, and then it was January 1, 2000, and the sky did not fall, there was planning and there was preparation.” With respect to DSCSA, Bernstein said that “the supply chain has been preparing for this for ten years so the sky shouldn’t fall. Yet procrastinators should get their act together and start applying for and apply for a WEE if you need one.”

Bernstein acknowledged, however, that she is worried about two things: supply chain disruptions due to missing data or errors, and the “lack of appropriate mechanisms for the exchange of information” about WEE requests.

Bernstein said that “there is no one database, FDA has said they will not be publicly stating who gets a WEE. So, it is incumbent on the WEE holder to share the information with their trading partners. I don’t believe the supply chain is ready to deal with all these waivers so there needs to be greater transparency and there needs to be a greater ability to know who has the WEE for which product and which transaction.”

Legal experts note confusion about DSCSA waivers, exceptions, and exemptions

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