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DTC Review Will Cost Industry $83,000 Per Ad Under FDA’s Final PDUFA Plan

Executive Summary

FDA expects to charge companies $83,000 per advertisement under a pre-review program included as part of the agency's proposal for renewal of the prescription drug user fee program

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DTC Fines May Be More Useful To Advertising Opponents Than An FDA Ban

Opponents of direct-to-consumer television ads will be better off with FDA having authority to fine companies for false and misleading television ads than they would have been if the agency was given the power to simply ban such ads, according to Scott Lassman, former Senior Assistant General Counsel at Pharmaceutical Research and Manufacturers of America

DTC Fines May Be More Useful To Advertising Opponents Than An FDA Ban

Opponents of direct-to-consumer television ads will be better off with FDA having authority to fine companies for false and misleading television ads than they would have been if the agency was given the power to simply ban such ads, according to Scott Lassman, former Senior Assistant General Counsel at Pharmaceutical Research and Manufacturers of America

DTC Advisory Review Fee To Vary Based On Number Of Expected Submissions

Under the Prescription Drug User Fee Act agreement between FDA and industry, the level of user fees for advisory review of direct-to-consumer television ads will depend on the number of ads sponsors expect to submit for review during a given year

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