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Executive Summary

FDA's OTC monograph regulatory paperjam will begin to break up by the end of this year, FDA OTC Drug Evaluation Div. Director William Gilbertson, PharmD, announced at the Proprietary Assn.'s (P-A) annual Research & Scientific Development Conference in New York City Dec. 5. "We have worked very hard and diligently, especially over the last few weeks, to resolve the so-called logjam, which I am very happy to say is going to be resolved very soon," Gilbertson told the P-A meeting. FDA's regulation process has been on a virtual hold for the past two years as a result of meticulous reviews by HHS and the Office of Management & Budget. Almost half of FDA's more than 100 regulatory projects which have been delayed by HHS/OMB scrutiny are OTC related initiatives. Gilbertson predicted that the first round of the new monograph documents would be released on or about Dec. 19. Some nine interrelated documents are expected to be published at that time, Gilbertson said, including the Nasal Decongestant section of the Cough/Cold monograph and the Laxative, Acne and Anthelmintic documents. Also included will be those for Hair Grower/Loss, Hypo/Hyperphosphatemia, Stomach Acidifiers, Poison Treatment and the Aphrodisiacs. The FDAer noted that the comment period on all of these documents will be extended from the standard 60 days to 120 days "to ease the time limitation burden on those parties commenting on more than one document." For those that have Category III conditions, Gilbertson said, the one year time period for the submission of new information and data, and two months for further response, will be in effect. Gilbertson updated the P-A group on the status of other monograph documents expected to break out of the publishing logjam in the near future, including major sections of the Antimicrobial, Cough/Cold, and Oral Cavity, and the Internal Analgesic. [Gilbertson's monograph publication timeframe estimates are shown in box at left.] According to Gilbertson, the Antimicrobial final monograph will be divided into two major sections, the first of which will deal with eight specific antiseptics. Gilbertson told the P-A group that this section will be "dramatically different than what you saw before," and that it is out of the OTC division and should appear "sometime in the first part of the year." The other section will cover "antiseptics per se, the professional uses," Gilbertson said, "and may need a little more time and effort." The Internal Analgesic and the other sections of the Cough/Cold monograph that have not yet appeared, "have long left my division," Gilbertson said, and "hopefully will be out in the near future." Gilbertson noted that the Oral Cavity monograph is another large document that has been broken into two segments: one covering non-antimicrobials is nearing clearance, while the antimicrobials document is further off. Gilbertson said that it appears that plaque will be included in the review and considered as an old claim, "at least for the mechanical actions that are employed in reducing plaque." Chemical action for reducing plaque will also probably be part of the review, Gilbertson said. The FDAer commented that the Antidiarrheal document has begun "moving again." He said that bismuth subsalicylate will be officially classified into Category III in the upcoming documents, but that protocols of ongoing studies "have been submitted to upgrade the ingredient to Category I and look very promising." He said, however, that the issue of bismuth subsalicylate is complicated, and the agency has made no decision yet. The Antifungal monograph will probably not cover combinations of antifungals, Gilbertson commented, noting that some ingredients, such as hydrocortizone, have been evaluated under the DESI review. Sunscreens "remain a very low priority," Gilbertson commented, and the sunscreen document will probably not appear during 1985. Other documents for which publication does not appear imminent include those for Weight Control, Vaginal Contraceptive, Antiperspirant, and Skin Protectant products. Gilbertson also noted that the exclusivity of labeling policy statement is "under careful review in the very high levels of bureaucracy right now, and hopefully something will be said about that in the next couple of months." In addressing the current thinking at FDA in regard to the Rx to OTC switch issue, Gilbertson noted that FDA is considering ways to revise the existing procedures. FDA has already during this past year taken steps to improve its procedures, Gilbertson said. The agency's procedural review comes in response to all the suggestions that have been made "to improve the 'switch' system, to clarify the procedures, and to identify the 'switch' criteria -- not only in the case of ibuprofen, but for the other potential switch candidates in the future." Although the agency affirmed the current "switch" procedures as adequate in its October response to the Natl. Assn. of Pharmaceutical Mfrs.' (NAPM) petition to change them, Gilbertson said the agency "is concerned about this perceived need for changes" and is considering whether it "should open for public comment the question of the need to supplement the current procedures or to develop new and/or different procedures." He added that if the agency determines "that it would be in the public interest to do so, that determination would be published in a future Federal Register notice." During the question and answer period following Gilbertson's presentation, P-A President James Cope asked him to comment further on the future of new OTCs coming on the market: "Some in industry feel that since the OTC review, we have sort of caught up the whole OTC area as far as GRAS/GRAE goes, both in switch and in general recognition by the agency [and that] the future of new OTCs coming on the market will be almost exclusively via the NDA route; ANDA, supplement, whatever. Others feel based on the agency's own initiative in the metaproterenol switch that you can still go GRAS/GRAE. . . Once the OTC review is sort of finalized, what's the future route?" Cope asked. In general, Gilbertson said, "I do see a gray area where there is reason to believe that we will find . . . mechanisms, procedures and develop criteria for handling a lot of these so-called new things that are not in the monograph outside the spector of 'new drug' . . . I wouldn't necessarily feel that everything in the future is going to be handled through new drug applications." Chart omitted.

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