The FDA notice (here) states: “[T]he over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing 3 years.” When the new monograph system went into effect, it was designed to reduce time to decision making by eliminating the lengthy comment and rulemaking process as it transitioned to an Administrative Order process. The length of time for decision making is indicative of the speed that Monograph conditions are evaluated even under the new system. However, some of the issues proposed to be addressed are significant from a safety perspective and thus should receive a thorough review.
The notice lists 10 items from addressing “the generally recognized as safe and effective (GRASE) status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients”, to the hot button topic of addressing the GRASE status of OTC phenylephrine as an oral decongestant ingredient which has recently been publicized relative to the ingredient’s lack of effectiveness.
Some of the other topics that caught my eye include a review of the “GRASE status of OTC oral health care drug products containing benzocaine and/or phenol preparations labeled for anesthetic/analgesic indications.” One of my relatives was in town and had some mouth ulcers caused by a virus and he was in pain. He usually uses lidocaine viscous 2% for topical administration, but he had run out of the drug and did not have a prescription to secure a refill. In searching for an alternate product, I found a Benzocaine oral topical product but as a pharmacist was surprised that it came in a 20% solution. I thought that was quite a high concentration especially for an OTC product. Apparently, FDA is of the same mind as they plan to take a fresh look at the status of that monograph product. Another item addressed the active ingredient propylhexedrine in an age-old product sold as Benzadrex Nasal Inhaler used as a topical nasal decongestant. This product can interact with other sympathomimetics which could lead to a dangerous spike in blood pressure and irregular heart rhythms. In another activity the Agency also plans to re-assess the risks and benefits of cough/cold drug products in children under age 6 years.
Please review the list above for other potential activities regarding existing OTC monographs, and while the Agency likely won’t get a start on all of them this year, you can get a flavor of how some of the OTC Monograph resources will be targeted.