The following chart represents the planned activities of the FDA to address certain OTC monographs over the next three years. The agency notes that while this list is aspirational, the list is not binding (what is with the FDA?). For those of you familiar with the old OTC monograph process, three years does not seem like a long time, as many of the monographs took decades to finalize because those monographs had to go through the formal comment and rule-making process. The new monograph system is an administrative order process, not a rule-making process, and thus, is a more efficient and expedited way “to add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drug monographs, including GRASE determinations for drugs marketed under 505G(a)(3) of the Federal Food, Drug, and Cosmetic Act.” The process is also speeding up because there are now OTC user fees for the submission of new and certain changes to monographs. (see previous blog posts, here, here, as well as, Dr. Woodcock’s testimony on the new monograph system here.)
As you can see some of the issues, especially the pediatric acetaminophen dosing risks associated with codeine-containing cough medicine, and pediatric cough/cold product dosing for patients under the age of 6, have been discussed by the FDA and practitioners for many years. However, now the Agency is moving with a bit more vigor.
In addition, the FDA notice on the planned actions (here) also includes the following request for additional data from OTC manufacturers and sellers.
Keep an eye out over the next few years for the Agency final action on these and possible other OTC monograph issues.
