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Executive Summary

The FDA Generic Drug Division's 180-day statutory limit for the review of ANDA petitions could be used to expedite the approval of Rx-to-OTC switches, FDA Generic Drug Division Director Marvin Seife, MD, told the Proprietary Association's Research & Scientific Development Conference in Philadelphia. In a Nov. 12 "regulatory roundtable" session, Seife nd Generic Division Review Support Branch Chief David Rosen expressed a willingness to help expedite switches by moving applications under the auspices of the Generic Drug Division. Seife and Rosen outlined a two-step approach to such a transfer. The suggestions from the two FDAers echo a recommendation made by P-A President Jim Cope at the association's 1986 annual meeting. Cope suggested that the agency's high level of productivity in ANDA reviews might be used to breathe new life into the Rx-to-OTC effort ("The Pink Sheet" May 19, 1986, p. 6). In his description of the two-step ANDA switch process, Rosen explained that applicants first have "to come in and get the product approved as . . . an Rx product; then a second step post-approval, you come in with a supplement to your application . . . which basically provides us with clinical data to support the change you want to make." At that point, FDA can "bring that supplement to the appropriate [drug review] office," Rosen continued. "And one of the nice things about that is that you get to work on our time clock, rather than on theirs." Seife agreed: "The advantage of coming to us is that statutory time clock. We honor that 180-day limit . . . so you get your approval and then come in with your supplement . . . think it out with us, and then we'll take the active role in seeing where we can go from there." Rosen cautioned, however, that the approach has not been used, and therefore involves some risk. "This is a new process, we haven't done this yet and we don't know if it's going to work. But we'll give it a try; we'll give it our best shot." Co-panelist and D.C. attorney Robert Pinco (Finley Kumble Wagner) reiterated Rosen's caution. His remarks were in response to a question regarding the effectiveness of the approach for a switch involving a major change, such as a lower dose, or a new indication. Pinco said the ANDA supplement approach "is not a panacea; it's not the final answer. Marvin [Seife] has some limitations when he sends this information down" to the drug review division for a consultation. "If it's really a dramatic change, you ought to do some negotiating early on to see that you're not going to run into a brick wall on the other end," Pinco advised. "All this [approach] does is assure that once you make that decision, once you get some agreement, rather than languishing in their NDA supplement route, you have another mechanism that might work fast." Seife also encouraged sponsors to pursue ANDA approvals for OTCs still covered by patents. "If you have your eye on an OTC product that has a full NDA and a patent that's going to lapse in five years, you can come in and file an ANDA and I'll give you an approval letter saying the effective date is 2002," he said.

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