Not before time last week, the SEC fired a shot across the bows of pharmaceutical and biotechnology companies that have been failing to accurately portray their dealings with the FDA. At the Annual Pharmaceutical Compliance Congress, SEC enforcement director Andrew Ceresney reportedly scolded biopharma companies over lapses in the accuracy of disclosures on their dealings with the FDA. Perhaps his words indicate that, after years of only scratching the surface of the problem, the SEC intends to get serious about addressing selective and misleading disclosure of material events, including biotech firms’ interactions with the FDA.
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