Pre-approval Promotion: Corporate Communications May Draw US FDA Scrutiny
Biopharma sponsors should start with information that needs to be disclosed to satisfy SEC rules and understand how a press release will be used to avoid running afoul of agency regulations, industry exec says; company contracts with investigators also should set limits on what they can say about an unapproved drug.
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With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.