In an effort spearheaded by the Federal Trade Commission (FTC), pharmaceutical companies have taken measures to remedy cases of alleged misuse of a U.S. Food and Drug Administration (FDA) database. The FTC’s initiative aims to combat attempts by drug manufacturers to artificially extend their exclusivity period.
Three major companies in the pharmaceutical sector, GlaxoSmithKline, Kaleo, and Impax Laboratories, have responded positively to this regulatory pressure. In an unprecedented move, these companies have requested that nearly all patents under question be delisted from the FDA database known as the Orange Book. The Orange Book lists all approved drugs with Therapeutic Equivalence Evaluations, serving as a key reference for the pharmaceutical industry.
Further details on the FTC’s campaign and the companies’ actions can be found in Law360’s coverage of this recent development.