On September 30, 2013, FLH Partner Brian J. Malkin was quoted in an article in "The Pink Sheet" entitled "GDUFA Plus One: Stakeholders, FDA Confident As Review Goals Near" (subscription or article fee required). The article summarized progress since the Generic Drug User Fee Act ("GDUFA") was enacted last year. GDUFA permitted FDA to collect fees from generic drug applicants and holders of drug master files ("DMFs") in exchange for certain efficiency enhancements and the promise for considerably shorter review times for abbreviated new drug applications ("ANDAs") in coming years. While FDA does not have to meet any ANDA review deadlines this year, starting with applications received from the fiscal year beginning October 1, 2014, FDA will need to review 60% within 15 months, then 75% within 15 months the following fiscal year, and 90% within 10 months of submission the next year.
FDA has reported progress with collecting fees, hiring new reviewers, and beginning to train these reviewers, as well as making a dent in the ANDA backlog. Regarding fees, FDA reported collecting $255 million collected in fiscal year 2013, about $44 million less than the target. GDUFA required FDA to hire 231 new employees in fiscal year 2013 and on September 11, 2013, FDA said it had hired 234 GDUFA-tagged employees, which FDA is in the process of training. FDA also has reported that it has reviewed about 40% of the application backlog since GDUFA went into effect and has conducted completeness assessments for about 900 DMFs. At the same time, however, review times have remained at a mean of 30+ months and have appeared to now be even longer. FDA has attributed part of this to the need to train new reviewers, which takes seasoned reviewers away from ANDA reviews, with the new reviewers not up to speed yet. Malkin was quoted in two sections on early improvement and budget sequesteration. Excerpts from the full quotations in the article include, for example:
There also does not appear to be much evidence that inspection parity is evolving. Brian Malkin, an attorney at Frommer, Lawrence and Haug, said there continue to be delays getting facilities reviewed and approved for first-to-file generic applicants.
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Budget sequestration may have hindered some implementation efforts, but Malkin said ultimately the changes taking place at FDA were necessary to improve its generic drug systems.