FDALAW Blog--FDA Issues Proposed Rule and Strategic Plan to Address Drug Shortages By Jennifer M. Thomas –

November 05, 2013

FDA Issues Proposed Rule and Strategic Plan to Address Drug Shortages

By Jennifer M. Thomas –

I have monitored the drug shortage issue over the last few years with professional interest and general concern (see here).  However, the situation was recently brought home to me when I took my four-month old in for her second round of vaccinations a few weeks ago, and was told that she would have to wait for one of her vaccinations because it was not available.  Of course, waiting won’t hurt her.  But I realized how much my anxiety and frustration would be compounded if the shortage could potentially impact my daughter’s health, or worse, if it actually did.  That unacceptable situation is faced by too many mothers and fathers every day in this country.

So it was with heightened personal interest that I read FDA’s recently releasedStrategic Plan for Preventing and Mitigating Drug Shortages (“Strategic Plan”), andProposed Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (“Proposed Rule”).  For those who lack the time to wade into these relatively lengthy documents, this post provides bullet-point highlights and a brief evaluation of each document.

Proposed Rule

• The Proposed Rule was authorized by the 2012 FDA Safety and Innovation Act (“FDASIA”).  (FDASIA: (1) expanded the FDCA’s drug shortage notification provision to all manufacturers of medically important approved or unapproved drugs – not just sole manufacturers of approved drugs – in cases of either a permanent discontinuation or a temporary interruption (FDASIA § 1001(a)); and (2) specifically authorized the Secretary to “by regulation apply [the notification requirement] to biological products . . . if the Secretary determines such inclusion would benefit the public health.”  FDASIA § 1001(a).  See our summary here).
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