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OTC NON-MONOGRAPH DRUG CLASSES: FDA CONSIDERING PETITION

Executive Summary

OTC NON-MONOGRAPH DRUG CLASSES: FDA CONSIDERING PETITION process to allow OTC marketing of some products without requiring a full NDA, FDA OTC Drug Division Director William Gilbertson, PharmD, told the Proprietary Association's Research and Scientific Development Conference Nov. 18. The non-monograph status refers to those drug classes, such as anticholinergics and daytime sedatives, that had been marketed OTC but were considered to be new drugs under the OTC rulemaking procedures and therefore not given monograph status. FDA is "thinking of ways to clarify [the non-monograph] status so the manufacturer that may still be interested [in marketing an OTC in those classes] will not necessarily have to come back through the drug proceedings to gain agency approval," Gilbertson said. "We're trying to find mechanisms, as these were marketed ingredients at one time, to allow a petition process to re-establish a new monograph for these." Gilbertson identified the non-monograph drug classes as one of several areas where the OTC regulations need to be clarified to allow for more flexibility in gaining marketing approval. The division director also cited the NDA-deviation procedure as an area that needs further clarification. Noting that the NDA deviation mechanism allows a sponsor to rely on monograph data to support the bulk of the NDA and submit new information only on the change, for example, a new strength or dosage form ("The Pink Sheet" Aug. 8, pp. 11-12), Gilbertson said: FDA "needs to clarify this regulation. We need to broaden it, I think, to describe exactly what precipitates the use of it [and] how far you can deviate from the monograph before it becomes a new drug situation." The NDA deviation route has not yet been used by any sponsors. However, as more monographs become final, the mechanism may gain favor as a means of getting a product to the market. Besides the NDA deviation route, FDA regulations currently allow only for a petition to amend the final monograph or a full NDA. Addressing the currently limited procedures for approval of products outside a monograph, Gilbertson said he would like to establish a "broad range of options ... ranging from no FDA interface ... to the [full] NDA at the other extreme." Gilbertson identified a "spectrum of options," beginning with "something along the line of having perhaps some premarket provisions listed in a regulation yet to be written which would spell out what things are safe and suitable to do without having to come to the FDA." Next "along the scale," Gilbertson continued, "could be a premarket notification, like with medical devices, where you say `Here's my new product.' You wait 90 days and if you don't hear from the FDA you market your product." For products needing more data, there could be a "monograph supplementation, where you could attempt to get FDA approval for a particular product in the public domain, but get some kind of exclusivity for a short period of time for your product before your petition was then re-examined as something that could be generally recognized ... and put in the monograph for other people to use." Further down the spectrum would be the NDA deviation and full NDA. Gilbertson said that "two major factors need to be addressed [for the future of OTCs]: the regulatory mechanisms to accomodate the future marketplace and an administrative process that clearly recognizes OTCs and sets a priority for them in the scheme of food and drug regulation."
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