Gilead Demonstrates the Folly of Formal Dispute Resolution

The FDA has a policy and a guidance for companies that want to pursue Formal Dispute Resolution (FDR) .   This lays out the procedure by which companies can appeal an FDA decision about a product.  It has been demonstrated many times by companies in the past, most recently Labopharm, a company that carried it to extremes, that going through the process is pretty much a waste of valuable patent time.

FDR is a process whereby a company appeals the decision by the FDA to the FDA, not an outside body.  In other words, it challenges the FDA to say "Oh, you know what?  We made a mistake and you are right.  Sorry!"  That is not likely to happen.  The appeal is made pretty much to the people who made the decision in the first place.  

Gilead received a Complete Response Letter from the FDA in September 2008 for its product aztreonam.  In November, Gilead initiated a FDR to ask the FDA to change its postion.  Yesterday the company announced that the FDA had submitted to them a reiteration of the position contained in the original Complete Response Letter.  

It is understandable that a company believes in its product.  During the review process, there is a great deal of opportunity for a company to make its best case for approval and to glean a pretty good understanding of the FDA's thinking.  Even when a company is surprised by the outcome, there is little reason to believe that going through an FDR process is going to bring the desired outcome.  In fact, an examination of the track record of FDR is pretty conclusive evidence that the FDR process is a dead end.  A company is far better off following the direction laid out in the Complete Response Letter.  Valuable time slips away otherwise.

As was stated in the Gilead release on the matter - 

Gilead has two ongoing clinical studies evaluating aztreonam for inhalation solution. The company has not yet discussed with the 


 whether or not either of these studies would be sufficient to address the FDA’s requirements or whether Gilead will need to design and conduct a new study. 

This entry was posted in Complete Response Letters. Bookmark the permalink.

1 Response to Gilead Demonstrates the Folly of Formal Dispute Resolution

  1. CMC Guy says:

    Most industry people know the futility of FDR process (and other dealings with FDA that have any associated controversy) and is a “no win” because even if by odd chance decision overturned the company is likely to bear a “black mark” in all future interactions.

Comments are closed.