Significant Marketed Unapproved Drugs FDA Enforcement Action In the Works at FDA

August 20, 2007

Since FDA announced its current enforcement policy for marketed unapproved drug products in a June 2006 Compliance Policy Guide (“CPG”), the Agency has taken various company- and product-specific enforcement actions.  We have previously reported on some of these enforcement actions (here, here, and here).   FDA has not, however, launched a whole-scale enforcement effort, as many companies had feared when FDA issued the CPG.  That may change.

We recently learned that FDA is in the midst of planning enforcement action against companies marketing and distributing unapproved prescription drugs that, according to one source, would seek to remove almost all such drug products from the market within the next few years.  We believe that the enforcement action FDA is planning is likely to be class-based.  For example, FDA might take enforcement action (through a Federal Register notice and/or Warning Letters) against all marketed unapproved prescription cough/cold drugs products. 

FDA’s anticipated enforcement initiative comes on the heels of the Agency’s January 2007 “Marketed Unapproved Drugs Workshop.”  The workshop was widely viewed as an effort by FDA to encourage companies to seek approval for their marketed unapproved drugs, rather than to explain the Agency’s CPG enforcement policies.  In what could be viewed as foreshadowing of anticipated future enforcement action, FDA Commissioner Dr. Andrew von Eschenbach commented during the workshop:

The FDA is seriously committed to resolving the problem of unapproved drugs and it is because the FDA is committed to assuring the patients that they are going to be able to obtain drugs for themselves and their children and their grandchildren not just on the hope that they are safe but based on the fact that FDA has reviewed the evidence and the labeling that defines the conditions under which that drug is safe and effective.  It is our responsibility and our mission to fulfill that commitment to the American people . . . .  Rather than working on a piecemeal basis, company or company or drug by drug, what we have wanted to do is to address this problem globally.  

Copies of the presentations made at the workshop are available here, and a transcript of the workshop is available here. 

We will continue to update our loyal FDA Law Blog readers as we learn more information.


  • FDA Marketed Unapproved Drugs Website
  • February 2007 RAPS FOCUS Article on Marketed Unapproved Drugs

Categories: Enforcement