Keeping an Eye on FDA When There is No FDA

It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown.  That said, an agency that regulates one-quarter of the U.S. economy does not come to a complete stop.

Warning Letters. For example, as a subscriber to notices regarding warning letters, I did receive an email this morning stating that the Warning Letters page had been updated.  These were general FDA warning letters, not letters posted by the Office of Prescription Drug Promotion – for which the latest letter posted was July 31.  However, sure enough, the general warning letters page lists its last update as being October 1.

Twitter Feeds. There was a notice put out yesterday, via Twitter, that all U.S. government twitter feeds would be inactive during the shut down, which includes all of the 11 FDA sponsored feeds, it would seem.  However, a tweet did go out this morning from @FDA_Drug_Info.  If you would like to monitor any FDA twitter activity during the shutdown, the @eyeonfda twitter feed has a compilation list of all FDA tweets where you can follow them all in one place.  The @FDArecalls feed stated that it would be posting limited notices and would not be monitoring or responding to tweets.

Press Office. I am informed that the media office is quite minimally staffed and that they will be issuing press releases related to actions funded by user fee programs.

Drug Applications and User Fees. Speaking of user fees, in the Drugs section of the Website, under Information for Industry, there is the following statement – and please note that hgh the emphasis by underscoring was added by me:

In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution (“lapse period”) agency operations will be limited to the following:

  • Emergency work involving the safety of human life or the protection of property;
  • Criminal law enforcement and work; and
  • Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Animal Generic Drug User Fee Act (AGDUFA) and Family Smoking, Prevention and Tobacco Control Act.  Carryover user fee balances will only be spent on activities for which fees are authorized under the Federal Food, Drug and Cosmetic Act (FD&C Act).

With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted.  This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.

Lapse Period. While new developments out of FDA may be difficult to report on, I will endeavor during the “lapse period” to shed light on (1) any changes and (2) looking at past FDA activities that could shed light on communications efforts for those working with industry by looking in-depth at the Warning Letters data base I have developed for any gems, among other things.

Let us hope that the lapse period lapses soon.

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