FDA: Ready, Set, Hike!

FDALogoTuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”).  The call was very thin on what their plan is, but that was the point.  Dr. Bernstein wanted everyone to know that they are working on an industry communication and engagement plan and they will share it with the industry as soon as it is ready.

The call itself was only 45 minutes long with less than 15 minutes of presentation by Dr. Bernstein and then 30 minutes of Q&A from callers.  In my view, all of the right questions were asked by the callers, but there were few answers other than, …we’re working on that…, or …we’ll figure that out with the industry in the coming months.  No surprise there, but that is in stark contrast to actions the FDA took on Monday related to compounding pharmacy regulations, the other Title in the DQSA.  Less than one week after the DQSA was signed into law—and that partial week had a two-day holiday in it(!)they released three new draft guidances related to compounding.  Now that takes preparation and planning!

I’m not going to recap the contents of the supply chain track and trace call because you can read Brian Daleiden’s excellent coverage here on the No BullWhip! blog, but I will say that my ears perked up when Dr. Bernstein was asked several questions about the possible end of the linear barcode rule for pharmaceuticals and biologics.  She reminded everyone that the FDA started a review of that rule several years ago and had collected public input.  She said they intend to take a close look at that rule again in light of the DQSA’s 2D barcode requirement.  I can’t wait.  More about that in a future essay.

Let me take this opportunity to remind you all to take a few minutes to let us know your current thinking about the DQSA and related topics in the 2014 RxTrace U.S. Pharma Traceability Survey.  Your input is anonymous and the survey is collected through a third-party (SurveyMonkey.com) (see “Announcing The 2014 RxTrace U.S. Pharma Traceability Survey”).  Watch for the aggregated results and analysis in the new year.  Click on this link or the banner ad below to be taken directly to the survey.2014 Traceability Survey Banner.556x93



One thought on “FDA: Ready, Set, Hike!”

  1. Looking forward to see the result of the survey. Highly recommendet to contribute and use 5 min. of this excelent Q/A session.

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