FDA's Good Review Management Practices guidance will formalize communications with SEC regarding potentially misleading statements made by sponsors in the preapproval stage, Acting Commissioner Crawford told the House Energy & Commerce/Oversight Subcommittee Oct. 10.

The upcoming guidance will "address this issue" of interaction between FDA and the Securities & Exchange Commission, Crawford said during the House Energy & Commerce/Oversight Subcommittee follow-up hearing on ImClone's Erbitux .

Crawford characterized the guidance as an attempt to "systematize" interactions that already occur routinely.

"FDA has a very effective relationship with the SEC," Crawford said. "To further strengthen inter-agency ties, FDA has undertaken a systematic review of our interactions with the talented and dedicated people at the SEC. We intend to systematize our interactions further based on discussions with those officials."

A review by the Office of Chief Counsel reported that FDA and SEC have a "productive" relationship, Crawford said. "These are actually two executive branch agencies that interact well with each other," he noted. "The frequency of contact is daily on both sides. They initiate contact to FDA on subject matter areas and we initiate also. So it's working."

Crawford highlighted the agency's coordination with SEC as one of three responses to the Erbitux investigation. A second element of the agency's response will also take shape through the GRMP initiative: FDA is promulgating a new policy on review/sponsor communications (see ¹ Also see "FDA Emphasizing Written Communication With Sponsors On Pending NDAs" - Pink Sheet, 14 October, 2002.).

FDA is also proposing to transfer most biological product reviews from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research.

Crawford's discussion of FDA's relationship with SEC is in part an effort to head off interest in expanding the agency's mandate to include close monitoring of pre-approval communications with investors.

During the hearing, Oversight Subcommittee Chairman Jim Greenwood (R-Penn.) repeated his interest in FDA's ability to correct false and misleading preapproval communications.

After the first Erbitux hearing in June, Greenwood suggested that legislation may be needed to enhance FDA's authority in that area (² Also see "Erbitux Inquiry Could Yield Pre-Approval Speech Bill – Rep. Greenwood" - Pink Sheet, 16 September, 2002., p. 12).

Crawford suggested that the "primary responsibility" to correct mis-statements in the preapproval stage rests with SEC.

"FDA's statutory mandate helps to ensure that patients have access to safe and effective drug products," he said. "That is our goal during the preapproval stage."

"While FDA has tried to correct false and misleading statements in appropriate circumstances, the primary responsibility is not with FDA, but with the Securities & Exchange Commission," he declared.

SEC "has broad authority under the securities laws to take action against any sponsor that makes a false and misleading statement." Such actions are "commonplace," Crawford maintained.

The acting commissioner noted that FDA has policies in place to address false and misleading statements made by sponsors about unapproved products.

FDA does on occasion send "untitled" letters to firms that it believes are making misleading representations about pending products. The agency could follow-up with a warning letter. In an extreme case, the agency has the authority to suspend review of the application, although Crawford acknowledged that the agency has yet to take such an action.

Rep. Bart Stupak (D-Mich.) expressed concern, however, that FDA's enforcement actions are not "rigorous" enough to correct misleading statements.

"I'm concerned that the enforcement of the FDA in cases like this is always after the fact and it is not very rigorous even when it is," Stupak declared.

Crawford responded that "firms generally will acquiesce to what FDA's requests are." He acknowledged that FDA never asked ImClone to correct any information about the status of Erbitux.

FDA/SEC Communication Will Be “Systematized” In Response To Erbitux

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