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FRAUD POLICY IMPLEMENTATION HELPS TO REDUCE ANDA BACKLOG BY 80

Executive Summary

FRAUD POLICY IMPLEMENTATION HELPS TO REDUCE ANDA BACKLOG BY 80 applications during September, Generic Drug Office Director Roger Williams, MD, told an Oct. 8 meeting of the National Pharmaceutical Alliance in Washington, D.C. As of Sept. 30, "our total backlog is just above 800, taking into account the effect of the fraud policy," Williams said. That total returns the backlog to "where we were when the scandal started," Williams added. The fraud policy, made final Sept. 12, allows FDA to require firms found to have submitted fraudulent data to remove pending applications and resubmit them after they have been audited ("The Pink Sheet" Sept. 16, T&G-4). The number of ANDAs pending for longer than the statutory 180 day review limit also decreased sharply in September, according to Williams. At month's end, the generics office had 294 overdue ANDAs, down from 346 at the start of the month. "I think it is a substantial improvement," Williams said, but cautioned: "We'll see an increase in applications as the industry recovers" and as firms resubmit some of the withdrawn applications. The fraud policy also helped FDA substantially reduce its backlog of pending ANDA supplements, Williams said. The Generics Office had approximately 1,500 supplements pending at the end of September, down by about 500 from the beginning of the month, Williams said. The disproportionate decrease in supplements compared to full ANDAs apparently is the result of previous ANDA withdrawals at FDA's or a company's request in the wake of fraud allegations. FDA's increased approval rate has also helped whittle away the backlog, Williams added. September was the second consecutive month of 21 ANDA approvals. The approval rate, however, "is a very fluid number," Williams cautioned, "and there will be months coming up where we fall below" 20. "You'll recall that we're trying to balance many things, the inspection in the field, our review process, the quality of your applications, so we can't always guarantee" the approval rate, Williams told the generic manufacturers association. "But we think if you look at the averages over the last several months there's been a clear trend upward." Williams noted, though, that total actions by the office were down in September. Recent promotions of reviewing chemists could also lower the approval rate as FDA searches for replacements, Williams added. FDA Compliance Office Director Dan Michels indicated to NPA that stepped up inspections of generic firms, one reason cited for increased review times, would not abate in the near future. Given the continued discovery of manufacturing deficiencies during these inspections, Michels said, "I would not be comfortable" with a decrease in their frequency. Williams also outlined his office's thinking on a proposed expedited review policy for "blockbuster" generic drugs. FDA requested comments on the idea in a May 30 Federal Register notice ("The Pink Sheet" June 3, p. 9). The Office of Generic Drugs hopes to send a draft policy to Commissioner Kessler in November. Although the comments from both the branded and generic industries in response to the notice were overwhelmingly negative, Kessler told the Rep. Dingell's (D-Mich.) House Oversight Subcommittee Sept. 12 that he supported expedited review for generics in certain cases ("The Pink Sheet" Sept. 16, p. 7). "The Office of Generic Drugs is in full support of that position," Williams said. The office is considering a policy that would expedite ANDA reviews in three cases: a "national emergency," situations presenting a "public health issue" such as a short supply of a drug or safety concerns, and, at the commissioner's discretion, in cases of "economically important" drugs when industry or FDA actions hamper the progress of a drug. Williams acknowledged that the last category is controversial, but emphasized that "we see this blockbuster policy occurring rarely."
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