FDA To Work With SEC To Regulate Pharmaceutical Company Statements

FDA and the Securities and Exchange Commission on Thursday outlined new measures "to enhance the public's protection against false and misleading information" issued by FDA-regulated companies about their drugs' development, the AP/Houston Chronicle reports (Gordon, AP/Houston Chronicle, 2/5). FDA began re-examining procedures for informing drug makers about their applications' status for approval following the 2002 ImClone Systems insider-trading case, in which company officials received "unofficial indications" that FDA would likely deny its application for cancer drug Erbitux, according to the Wall Street Journal (Solomon/Wilde Mathews, Wall Street Journal, 2/5). The new plan will establish a referral procedure for FDA employees to "tip off" the SEC to publicly traded companies' false or misleading statements and give specific FDA employees a "blanket authorization" to share private data with the SEC, the Boston Globe reports. FDA also announced that it has chosen a liaison officer with the SEC and has begun planning training opportunities (Kerber, Boston Globe, 2/6). However, officials said the new measures will not affect the agency's restrictions on disclosing proprietary information about drug reviews, which remain confidential under federal law (Wall Street Journal, 2/6). FDA Commissioner Mark McClellan said that if FDA employees suspect misleading or erroneous statements by a company, "We have a new process to bring them to the attention of the SEC staff as quickly and efficiently as possible" (AP/Houston Chronicle, 2/5). Rep. Jim Greenwood (R-Pa.) who questioned FDA and SEC cooperation last month, said on Thursday that he was "very impressed and encouraged" by the new measures (Boston Globe, 2/5).