DEA Representative States it has Received the HHS Recommendation on Rescheduling of Hydrocodone

By John A. Gilbert & Delia A. Deschaine –

As previously reported here, late last year, CDER Director, Janet Woodcock issued a statement indicating FDA’s intent to recommend that DEA reclassify hydrocodone-combination products in Schedule II.  (We note that scheduling recommendations are made to DEA by the Assistant Secretary for Health at HHS, but in practice FDA is generally responsible for drafting the recommendation.)  And, as also previously reported here, on December 26, 2013, a Citizen Petition (“CP”) was filed with FDA requesting that the agency modify any such recommendation to exclude lower strength hydrocodone-bitartrate products.  The CP was intended to at least put HHS and FDA on notice of concerns about the rescheduling of these products; it seems to have also had the effect of smoking out where HHS and DEA are in the rescheduling process.  

In an article published on February 7th by FDA Week/Inside Health Policy, a DEA Spokeswoman is quoted as saying that the agency has received the recommendation from HHS and the proposal is under review.  DEA did not state when the recommendation was received by the agency.  Both agencies have traditionally considered such communication as inter-agency communications not subject to public disclosure.  Further, it appears that neither HHS nor DEA has disclosed what the recommendation is at this point.  It is fair to assume that the recommendation is consistent with CDER Director’s statement – that all hydrocodone-combination products be reclassified in Schedule II. 

At some point DEA will have to issue a Notice of Proposed Rulemaking.  At that point the industry will have the opportunity to comment on any proposed change in the scheduling.