New Carrots, New Sticks

Friday, August 07, 2009

Dr. Margaret Hamburg made some significant remarks at the Food and Drug Law Institute yesterday that are well-worth reading in full. 

Here are some of my top-line impressions of the most significant points:

  • Close-Out Letters
    Everyone expected FDA to add new enforcement mechanisms.  It's nice to see, however, that they're also thinking about ways for industry to make good.  As it stands, warning letters are a permanent testament to what may have been a temporary failing.  By proposing that FDA will also issue a letter when problems have been corrected, Dr. Hamburg is providing a reasonable mechanism to more easily distinguish good actors from bad ones.

  • Follow-Up Inspections
    The flip side of close-out letters is that FDA appears determined to resolve warning letters in a short, specific period of time.  In the past, some warning letters have just hung out until further enforcement action was taken.  It appears they are looking to shorten that window considerably.

  • 15-Day Response
    Currently, different types of findings have different mandated response times.  It sounds like they're going to standardize response times on 483s to 15 working days.  This fits nicely with the follow-up / close-out objectives.  Dr. Hamburg also pretty strongly stated that this response period may be all the time you get to correct your problems.  Further enforcement won't necessarily wait until additional warnings are issued.

  • Bypassing OGC
    Historically, warning letters had to go through extensive review by the Office of General Council.  This office rather famously became a bottleneck for enforcement activity during the Bush years and under the new regime, such reviews will be limited to narrow legal issues.  You don't want to bet against the power of political shenanigans, but reducing the influence that mid-level political appointees have over the enforcement workflow is probably an improvement.

  • Increased Volume
    Dr. Hamburg cited the level of regulatory activity around H1N1 products as something that, going forward, would not be considered extraordinary.  Given that the level of H1N1 activity was, by recent historical standards, completely off the charts, it's not difficult to see what she's getting at here.

  • Speedier, More Local Enforcement
    Dr. Hamburg also alluded, none-too-subtly, to a willingness to work with state and local law enforcement when doing so would lead to speedier enforcement action.  It's difficult to know if this is the kind of thing that is meant as a threat more than a promise, but one hopes not to see very many cases where the county sheriff is kicking down doors in a clean room. 

Tags: Enforcement, FDA, FDA 101, Obama Administration, Warning Letters

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