In a pre-publication Federal Register Notice on Friday, August 5, 2016, FDA announced the reopening of the comment period on the issue of OTC Monograph User fees until October 6, 2016.  In addition, the Notice indicated that the FDA “will hold a Webinar for stakeholders on September 6, 2016.  This Webinar is intended to be a follow-up to the June 10, 2016, public meeting and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016.”

“FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.” To date, there have been 7 comments submitted to the docket.  We thought we would take a look at the general feel of the comments submitted so far.

There were 7 sets of comments submitted to date.  Some of the commenters favored a user-fee system due to the underfunding of the OTC monograph review program and some did not.  Here is a summary of the types of comments FDA has received to date.

  • User fees only for stimulation of innovation (new products). Do not use fees to pay for finalizing old monographs.
  • The monographs need to remain ingredient-specific, rather than product-specific.
  • Suggestions of incentives, such as exclusivity to stimulate innovation.
  • Appropriated funds should be used to finalize pending monographs and the development of a new monograph system.
  • Target fees to a new use or new ingredient, but tie to a period of exclusivity.
  • Do not adopt user fees for OTC monographs because of low margins on these products and, once a monograph is published, anyone can piggyback on the monograph (free ride). This commenter also believes that fees may destabilize the OTC market, especially since larger manufacturers would be less affected by fees and smaller manufacturers would be disproportionately impacted by fees.
  • Fees should be applied only to finished dosage form manufacturers or facility, but not ingredient suppliers (a dig at the GDUFA model was the aim of this comment).
  • Some proposed annual product fees to assure that everyone pays their way.
  • Any OTC user fees should only be used for the OTC monograph review process.
  • Reasonable action goals should be set if any user-fee program is put into place.

It was somewhat surprising that there were not more commenters.  Perhaps it is because that these are initial discussions and no details or proper plan has been laid out yet.  The impact of any user-fee program on OTC products would obviously be a big change from the way FDA does business for the products that require affirmative FDA approval.  Any such program would cover hundreds s of thousands of potential products.  FDA will likely go slowly on this process, especially if consumers may be adversely impacted by pricing decisions or by reductions in innovation.