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Executive Summary

OTC SWITCH CANDIDATES: THREE YEARS OF "HIGH USE" Rx MAY BE ENOUGH to satisfy FDA that the product can be made available over- the-counter, Neil Abel, FDA Office of Small Business, Scientific, and Trade Affairs, told a joint International Society for Pharmaceutical Engineering/FDA conference March 12. "Usually within the first three years you are going to find most of your adverse events," Abel said. "High use also is likely to mean that you'll pick up a broad range of uses of that product with concomitant diseases, other products, and other risk factors," he added. A company needs to offer a substantial "base of information" in its application, Abel pointed out. Three years time would be enough, he added, only if the company began gathering solid data immediately after prescription drug approval. He indicated that data from the product's prescription and OTC use in countries outside the U.S. also could be an important source of data for a switch. "The FDA has tried to get as many products as we can from Rx to OTC," Abel said. "The criteria for switching is not set in any type of concrete," he added. "We're interested in any way that you can provide us information on the switch." Acknowledging that "the agency has fewer applications" for switches than had been expected, Abel suggested that "a primary reason is trying to find an appropriate indication" for an OTC version of a prescription drug. "For example," he said, "a firm that has a product for ulcers must come up with solid clinical data for use that is suitable for an OTC product, such as heartburn." Marion Merrell Dow recently said that an OTC version of its anti-ulcer drug Carafate (sucralfate) was being slowed down by the need to settle on an indication ("The Pink Sheet" March 4, p. 14). Abel reminded the meeting that Center for Drug Evaluation and Research Director Carl Peck, MD, "has basically outlined his principles for switching" ("The Pink Sheet" Feb. 4, T&G-15). Peck's influence is "always felt through the center," Abel said. "From listening to Peck, [it is] very important to him that we strive to get the lowest effective dose for a particular product," Abel added. "I also believe, [based] on discussions with the Commissioner and some other people, that we will probably form an OTC advisory committee strictly for OTCs," Abel said. OTC Drug Evaluation Division Director William Gilbertson said in January that the formation of such a committee is "fairly certain" ("The Pink Sheet" Feb. 4, T&G-15). The remaining uncertainty, Abel indicated, involves the status of the OTC group at FDA. With the monograph process apparently winding down toward a 1993 conclusion date ("The Pink Sheet" March 18, p. 15), there is debate within the agency about whether the OTC group should act as "consultants" to other reviewing divisions or actually conduct reviews with its own medical staff. "If OTC gets their own office it will be a lot better for the switch capability," Abel said. "I think both Dr. Peck and Dr. Kessler are very supportive about putting more emphasis into the OTC area and trying to help the switch process."

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