"After years of concern, the Food and Drug Administration issued draft guidelines that are designed to limit the use of citizen petitions to delay approval of generic drugs or biosimilars...
"'We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients,'
FDA Commissioner Scott Gottlieb said in a statement...
"....A 2016 analysis by Michael Carrier, a Rutgers University School of Law professor who specializes in anticompetitive practices and intellectual property, found that brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015, although the FDA denied more than 9 out of every 10 petitions. In a separate analysis, which he co-authored, Carrier cited as an example of abuse a petition filed by Mylan to thwart a rival to its EpiPen device."