Ronald Davis Comment on Authorized Generic Drug Study

COMMENTS ON PROPOSED INFORMATION AND DOCUMENT REQUESTS AUTHORIZED GENERIC DRUG STUDY FTC Project No. P062105 Ronald W. Davis ATTORNEY Atlanta, GA 30307 1 I. INTRODUCTION AND OVERVIEW These comments, submitted on behalf of an undisclosed client, address the Fed-1eral Trade Commission’s Comment Request with respect to FTC Project No. P062105, requesting observations on the relevance and burden of proposed requests for documents and information to be issued in connection with a planned study by the FTC of the com-2petitive effects of authorized generic drugs.These comments are addressed principally to • “whether the proposed collections of information are necessary for the proper performance of the functions of the FTC, including whether the in-formation will have practical utility,” and • “ways to enhance the quality, utility, and clarity of the information to be 3collected.” A main purpose of the proposed study is to determine the extent, if any, to which the expectation of price competition from authorized generics during the 180-day market-ing exclusivity period decreases the incentive of generic manufacturers to enter the mar-ket and gain exclusivity by filing paragraph IV certifications—and, in consequence, de-ters market entry to the detriment of consumers. To answer this question, the Comment Request calls for production of extensive information and documents ...