Securities and Exchange Commission, FDA Begin To Draft Plan To Reduce Investigation Times
Officials at the Securities and Exchange Commission and the FDA have begun to draft a plan to help reduce investigation times for cases in which pharmaceutical companies allegedly mislead investors about the chances for approval of experimental medications, Bloomberg/Philadelphia Inquirer reports. Mark Braswell, a former SEC enforcement attorney and currently a partner at Venable LLP, said, "Approval announcements, or failures to gain approval, have a tremendous impact on stock price. This would make referrals move faster, and that's going to be good for investors." SEC officials currently must inform the FDA in writing that the commission will not release information provided by the agency in such investigations, which can delay the investigations, and FDA officials have said that federal law does not allow the agency to share some information about such cases with the SEC. In addition, although the FDA often informs pharmaceutical companies that they must conduct more research on experimental medications under consideration for approval, the companies do not have to inform investors about such requests. The House Energy and Commerce Committee in 2002 ordered the FDA to improve communications with the SEC, and SEC Chair William Donaldson and FDA Commissioner Mark McClellan discussed the issue last month (Dooley/Schmidt, Bloomberg/Philadelphia Inquirer, 1/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.