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Generic Drug Fees Could Be Based On Product Complexity

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seeks comments at Sept. 17 public hearing on issues surrounding development of an ANDA user fee program, including whether applications for more complex products should carry a higher fee and whether fees should be used to support postmarketing safety oversight.

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Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?

The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.

Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?

The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.

ANDA User Fee Negotiations: A Big-Firm Coalition Tackles The Big Backlog

FDA has long negotiated its brand user fee program with two distinct but closely aligned industry groups: the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization. Now the agency will be using those same discussion techniques as it develops the generic drug user fee program.

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