Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG

December 14, 2011

By Kurt R. Karst –      

We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion.  And it did.  One comment in particular that we received from an authoritative source caught our attention and deserves greater airing.  It concerns FDA’s interpretation of the September 19, 2011 iteration of the Agency’s Unapproved Drugs CPG as it applies to products marketed pursuant to FDA’s enforcement discretion under a pending Drug Efficacy Study Implementation (“DESI”) program proceeding. 

As we previously reported, the September 2011 Unapproved Drugs CPG is a line in the sand of sorts.  It says that FDA’s risk-based enforcement approach discussed in the June 2006 version of the CPG continues to apply, but only to unapproved drug products on the market as of September 19, 2011:

The enforcement priorities and potential exercise of enforcement discretion discussed in this guidance apply only to unapproved drug products that are being commercially used or sold as of September 19, 2011.  All unapproved drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth below.  In light of the notice provided by this guidance, we believe it is inappropriate to exercise enforcement discretion with respect to unapproved drugs that a company (including a manufacturer or distributor) begins marketing after September 19, 2011.

Since then, FDA has clarified for us that prenatal products are not exempt from the revised CPG, stating generally that “[a]ny unapproved drug that enters the market on or after 9/19/11 is subject to immediate enforcement action without prior notice,” and more specifically, that “prenatal vitamins are not excepted from this CPG.”  FDA is apparently also taking a hard line on the post-September 19, 2011 marketing of drug products subject to a pending DESI proceeding. 

As we noted earlier this week, the September 2011 Unapproved Drugs CPG states that although “any product that is being marketed illegally is subject to FDA enforcement action at any time,” there is a general exception to this policy for marketed unapproved drugs subject to an ongoing DESI proceeding, provided certain conditions are met.  In short, FDA says that “[i]t is the Agency’s longstanding policy that products subject to an ongoing DESI proceeding may remain on the market during the pendency of the proceeding.”  Unapproved Drugs CPG at 10 (emphasis added).   The phrase “may remain on the market” is important here, because FDA’s Office of Compliance is reportedly of the opinion that only those drug products subject to a pending DESI proceeding on the market before September 19, 2011 are subject to the policy.  A drug product that may nevertheless meet the policy parameters that is first marketed after that date will not, we understand, be accorded enforcement discretion. 

But there’s more . . . .

What if a company marketed a drug product subject to a pending DESI proceeding before September 19, 2011, and subsequent to that date contracted with a new distributor to market the same drug product?  That too, we understand, would fall outside of FDA’s ongoing DESI proceeding policy, such that FDA would apparently consider the new distributor’s drug product subject to enforcement action.  And how will FDA know if such a product has been marketed after September 19, 2011?  That’s where the recently revamped National Drug Code Directory will likely come into play.  It includes, among other things, a new “Start Marketing Date” category that would filled in based on registration/listing information submitted to FDA.  FDA will presumably use the information from the “Start Marketing Date” category to target enforcement action.