FDA Law Blog Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition January 29, 2014

By Delia A. Deschaine –

 

Various members of industry recently joined together in filing a citizen petition with FDA.  Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends to issue a scientific and medical evaluation and recommendation that DEA reschedule all hydrocodone combination products from their current placement in Schedule III to Schedule II.  The petitioners argue that reclassifying all combination hydrocodone products is inappropriate for myriad of public policy reasons.  Thus they request that FDA instead recommend DEA reclassify only hydrocodone combination products that contain hydrocodone bitartrate in a strength of 5 mg or higher.  Citizen Petition at 2.  While the petition is brief, it touches on several critical points that FDA and DEA will likely consider in determining whether to move forward with the rescheduling.