Yesterday, the FDA published the attached Notice announcing that it was time to consider “Modernizing” (a euphemism for enhancing the FDA’s regulatory authority) the regulation of drugs under the Over-The-Counter (OTC) Drug Review. To that end, the Agency announced that it was going to hold hearings on proposed changes to the OTC Monograph Process for the purpose of giving stakeholders an opportunity to present their views and ideas. The hearings will be held on March 25 and 26, 2014 at the FDA’s White Oak Campus. Meeting details on pages 10169 and 10172 of the Notice.

Background. The Notice establishes the FDA’s rationale for change: The OTC Monograph Process has become too cumbersome; FDA’s inability to quickly change finalized Monographs to reflect changes in science and address safety concerns; and Process’ inability to accommodate innovation and new products. While the FDA is positioning this as a basis to explore new ways to re-engineer the system and create a process that is more efficient and responsive to newly emerging information and evolving science, and allows for more rapid product innovation where appropriate, the obvious yet unstated purpose is to give the FDA greater authority over the category. The impetus for this power-grab may be the Natural Resource litigation which resulted in the reset of the Anti-Microbial Monograph.

Analysis. From a purely legal perspective, the FDA is ignoring the original basis for these OTC proceedings. The proceedings were established to provide a basis for proving the efficacy for old OTC drugs that were on the market before 1962. The Monograph Process was never intended to provide a marketing pathway for new innovation.

The changes the FDA is proposing are significant and will give the Agency far greater regulatory authority over OTC products and will streamline enforcement proceedings. Some of the changes the FDA is considering include the following:

  • Changing the process by which Monographs are finalized from a rule-making process to one in which Monographs are issued by Administrative Order of the FDA, thereby giving the Agency far greater control over the process;
  • Providing the FDA with greater ability to respond promptly to emerging “safety or effectiveness” issues and requiring additional information or data necessary to develop pediatric labeling where appropriate; and
  • Expanding the FDA’s control over individual products by allowing the Agency to obtain pre-market final formulation information, i.e. information on formula inactives which are “similar but less detailed” than what is currently required for NDAs. The Notice gives examples of the types of information the FDA would require, including labeling, quality, and pharmacokinetic information, which would permit the Agency to issue Guidances, presumably by class of active and/or therapeutic class.

Click here to view a brief summary of the FDA’s wish list, which is discussed in more detail on pages 10170-10171 of the Notice.