On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before.
Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
What We Can Learn
As stated on page four of the Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, the document is “intended to aid trading partners (manufacturers, repackagers, wholesale distributors, or dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product.” Since these terms and their definitions were already defined in the legislation, it would seem that the other piece to be provided would be how a company would investigate and handle them. This is a major area where the draft falls short. There is no detail around what these internal processes should look like; however, this is where Colombo and Wang say this room for interpretation should encourage action on behalf of all trading partners.