The IRS and Treasury have issued guidance (Rev. Proc. 2011-24) concerning a dispute resolution process for the new annual fee imposed on branded prescription pharmaceutical manufacturers and importers. Specifically, the Rev. Proc. provides the exclusive process available to covered entities to dispute the preliminary fee calculation expected to be issued on May 16, 2011, and request correction of claimed error(s) to be considered by the IRS that would be reflected in the final calculation expected to be issued on August 15, 2011.
Prior to such guidance, these covered entities had no formal administrative recourse to dispute an initial fee thought to be incorrect or computed in error. Covered entities will have less than 45 days to review the 2011 preliminary fee calculation, gather necessary information, and formulate a response.