Recently, two pharmaceutical companies announced that they would be seeking Formal Dispute Resolution (FDR) because of FDA decisions regarding their products. Genta announced in April that the company would be filing one over a non-approvable letter for their investigative product Genasense and Encysive announced their intent to file an FDR because of their third approvable letter outcome for Thelin.
According to the FDA Guidance on FDR, the FDA
"If the product underlying a procedural or scientific dispute is a PDUFA product, the Official should complete the review within 30 calendar days from the DRPM’s receipt of the formal request. The Official should contact the sponsor within the 30 day window via written response or telephone response (30 day response ). If the response is by telephone, the reviewing Official should provide a written confirmation of the formal dispute resolution outcome to the sponsor or applicant within 14 calendar days from the date of the telephone call. If FDA is unable to complete the review and respond within 30 days, the Official should notify the sponsor, explain the reasons for the delay, and discuss the time frame for completing the review."
So far as I can tell, there has not been a response to the Genta filing, or at least nothing listed in Genta’s press releases that I could find.
In December 2006, Labopharm announced that it was going after a Formal Dispute Resolution over Tramadol after the company received an approvable letter. However, pending the outcome of discussions with the FDA, the company apparently decided to forego the FDR. Then in May, they received a second approvable letter for Tramadol.
In 2002, Corixa announced the filing of an FDR for Bexxar after a second approvable letter was received from the FDA. After filing the FDR, the company provided further data that prompted the FDA to then put Bexxar back into active consideration and the company withdrew its FDR.
A device company in 2007 submitted an FDR and the panel recommended that the device not be approved.
While I do not pretend my search for FDRs was terribly exhaustive, the conclusion I think I’ve reached is that this does not seem a terribly productive method for getting a drug approved – at least in recent history. I could not find the FDR process used very often, and when it was used, I could not find an example where the drug was eventually approved. I may have found an example of a device, but the records were so sketchy, I decided not to include it.,
Perhaps most companies figure that since the appeal is being made to the very body that made the decision in the first place, the value of a formal proceeding to ask for reconsideration is not as useful as engaging in direct dialog with the agency and supplying further information.