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FDAnews Drug Daily Bulletin
June 20, 2012 | Vol. 9 No. 121
FDAAA’s Citizen Petition Reforms Failing to Stem Generic-Halting Hijinks: Study
A provision in the 2007 FDA Amendments Act (FDAAA) intended to limit the use of citizen petitions to block approvals of generic drugs has failed to change the behavior of brand companies, whose use of the petitions continues to rise, according to a new study. Such filings have increased in the past decade and 68 percent of petitions are filed by brand drugmakers, with more than three-fourth of brand petitions (78 percent) targeting generic drugs, according to a paper set to be published in the Cardozo Law Review by Michael Carrier and Daryl Wander, a law professor at the Rutgers School of Law–Camden and a recent graduate of the school, respectively.
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