Formal Dispute Resolution and the FDA – Revisiting the Issue

Given the holiday week, there is no Weekly Roundup this week, but my eye did catch an interesting tidbit that made me want to re-visit the issue of appealing an FDA decision.  I last wrote about it on July 17 and since then, there is more evidence that Formal Dispute Resolutions (FDR) are probably not the most productive pathway to approval. 

This week, the FDA issued a letter to Labopharm in which it announced that the appeal the company made to overturn an earlier agency decision to issue approvable letter for analgesic once-daily tramadol.  It wasn’t the first approvable letter issued, but the second for the product.

The company apparently is going to carry on its pursuit to overturn the approvable letter, according to a press release.  I stand by my earlier posting on the Formal Dispute Resolution.  If you would like to review it, the FDA has a Guidance on Formal Dispute Resolution

On August 6, Encysive Pharmaceuticals filed an FDR with the FDA.  On September 5, they got a response from the FDA denying the appeal.    The company issued a statement.  "We continue to believe that the issue raised by the FDA was sufficiently addressed in the NDA and we are reviewing the FDA’s response with external experts to determine the next step forward," said George Cole, President and Chief Executive Officer of Encysive.  Whatever that means.  Then, a few weeks later on September 24, the company issued a press release announcing new Phase III trials for their product

"Encysive believes it had successfully addressed all of the questions raised by the U.S. FDA in its New Drug Application (NDA) for Thelin in PAH. However, the Company has concluded after consulting with external experts that the best path forward for commercializing Thelin in the U.S. is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA."

Let’s do a little risk/benefit analysis here about FDRs. 

  • Benefit?  The only benefit is that the FDA would decide that it was wrong and that the company was right and that the agency doesn’t really need further information.  This would be in spite of two approvable letters.  And, remember, the appeal is being made to the agency that made the decision.  Also, I don’t know of a single successful appeal.  So the benefit, if it is there, is not likely.
  • Risk?  Well, in addition to being turned away from approval by two approvable letter, the image of the product suffers further when each appeal is denied.  From a communications perspective, unsuccessful appeals do little to build strong branding for the product.  In addition, one creates media milestones for each and every rejection by the FDA. 

In short, while appeals to the agency in the face of multiple approvable letters – an increasing happenstance this year at FDA – might be tempting for the sake of some outlet where the company can insist that a it is right about its product being appropriate for approval, it probably does little to promote the chances that the product will see the market any sooner than if one went ahead and met the conditions outlined in the approvable letter, as set out by the FDA.  Encysive could tell you that. 

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