Eli Lilly and Company - Public Comment on Authoried Generic Drug Study

.. '-'- ," ..,..- -.._,-. . . .,'""'._. .._. ", """ """-'"''''' --., '_ .--" ,. - ...- .-- ,... --.... . --- ''' .- ,-. ..._- .",-.-. .-- _... . ,- ,,- ';"'"" '--Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U. Phone 317433 5499 Fax 317 4333000 Mail rarmitagelCHilly.com June 5, 2006 Federal Trade Commission l35 (Anex J) Offce of the Secreta, Room H-, NW 600 Pennylvania AvenueWashigtn, DC 20580 Re: Authoried Generic Drug Study: FTC Project No. P062105; Request for Comments; Dear Sir or Mad: the opportty to submit comments on the Federal Trae Eli Lily and Company (Lily) appreciates Commssion s proposed collection of inormaton to analyze the economic effect of autoried generic drgs. The Commsion invited comments on, among other points necessar for the prope performance of the (w)hether the proposed collections of inormation are fuctions of the FTC, includi whether the inormation wil have practical utility. 71 Fed. Reg. 16779 (Apri 4, 2006). Lily s comments focus on the necessity and uti of the information to be collected in light of the stad goals of study. In sumary, LHly believes that a narw or isolated look at the issue of autoried th coupled with a broader anysis ofthe generics would be a meaingless exercise uness context in which the 180-dy exclusivity proviions of Hatch- Waxan operate. Indeed, any inormation related to the 180­day exclusivity proviions ...