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Executive Summary

Pharmacologic failures in treatment which result in a "serious" outcome should be submitted to FDA in 15-day alert reports under the adverse drug reaction reporting requirements of the NDA reg rewrite, FDA Office of Epidemiology and Biostatistics Director Gerald Faich, MD, said Aug. 8 at a seminar in Washington sponsored by the Drug Information Assn. Answering the question "Does the outcome have to be serious before the failure of [pharmacologic] action is considered significant and reportable," Faich said: "The way I would interpret the statement in the regulation is 'significant failure' and that means a failure seeming to occur at a rate higher than one would expect where the failure has a serious outcome. I think," Faich continued, FDA is "not concerned about failure of pharmacologic action where the end result is not serious to begin with." DIA's conference, entitled "Postmarketing Reporting of Adverse Drug Reactions," focused on FDA's draft guidelines on the NDA rewrite regs for reporting ADRs which go into effect Aug. 30. During a question and answer period, Faich indicated that FDA will revise the guidelines in "some months" and that a Q&A document would be issued within the next few weeks to serve as an aid in the interim. Faich was also questioned about a U.S. company's responsibility to report the experiences of unassociated foreign firms who market the same drug in other countries. He was asked: "For a company marketing product 'x' in the U.S. where the same product is marketed by a different company in a foreign country, is the U.S. company responsible for reporting serious or unexpected reactions from that foreign company?" Different Formulations Of Same Drug Require Periodic Reports For Each Approved NDA, Faich Says The FDAer told the conference that "when there's no relationship between that foreign marketer and your company [and] you didn't manufacture it [and] you're not the distributor, I guess [the answer] is no." However, Faich added that he would have to "take that one" back to the FDA and "talk about it a little." Asked what a brand name mfr. would do if it receives a report in which an unidentified generic is the suspect drug, Faich said: "I think that if it is a solicited report -- a report that comes about as a result of a marketing study you are conducting, then I think you have to make every effort possible to find out who the manufacturer of that generic was. And, if you don't find out, what I'd like to see you do is send it to one of the manufacturers of that generic." However, if the report is unsolicited, Faich said, FDA would "consider it a public service if you submitted it to us." Several questions were asked of the FDAer relating to ADR reporting requirements for different formulations of the same drug. Faich explained that "under these regulations, if you have an NDA for a product, it's got periodic reporting requirements. Indeed, each periodic report must go for each NDA. So if you have a product covered by three different NDAs because you've got three different formulations of the same product, that's three periodic reports." Faich also noted that OTC drugs are covered under the regulations only if they have NDAs. Faich was asked under which NDA a mfr. should submit a report if the formulation linked to the ADR was unknown. The FDAer told the conference to list the reaction on the form 1639 for one formulation and in the tabulation of the other formulation. "That way you're covered," he explained, "but for God's sake don't send us two 1639s because it will get double counted."

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