Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA’s Office of Prescription Drug Promotion (OPDP) last year issued two untitled letters to manufacturers alleging that pre-approval communications about investigational new drugs exceeded the scope of permissible “scientific exchange” under 21 C.F.R. § 312.7(a).1 This follows a seven-year period in which OPDP (and its predecessor, the Division of Drug Marketing, Advertising, and Communications (DDMAC)) issued no such letters, prior to which the number of letters had attained a fifteen-year high. The 2012 letters point up the importance of continued manufacturer attention to FDA’s interpretation of the pre-approval promotion rules, even as OPDP has been considering changes to § 312.7(a) since soliciting public comment on the issue in December 2011.
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Increased FDA scrutiny of pre-approval communications continued in 2012
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