FDA is drafting an internal policy on communication with sponsors that will address some of the issues raised during the House Energy & Commerce Committee hearing into the handling of ImClone's BLA for Erbitux .

Office of New Drugs Director John Jenkins, MD, is understood to be preparing the draft. FDA hopes to publish it for comment in the next month or two.

The policy is being developed under the rubric of the broader Good Review Management Practices initiative, undertaken as part of the Prescription Drug User Fee Act reauthorization.

The Center for Drug Evaluation & Research and the Center for Biologics Evaluation & Research are supposed to publish a GRMP guidance by the end of FY 2003 (¹ Also see "PDUFA III “Good Review Management Principles” To Stress Early Action" - Pink Sheet, 18 March, 2002., p. 3).

The drafting process for the policy on communication with sponsors began in July, shortly after the House hearing on the Erbitux review.

One of the issues highlighted during the hearing - and in follow-up commentary by the committee leadership - was the difference in communication policies between CBER and CDER (² Also see "Erbitux Inquiry Could Yield Pre-Approval Speech Bill – Rep. Greenwood" - Pink Sheet, 16 September, 2002., p. 12).

FDA testimony during the hearing highlighted different approaches taken by oncology reviewers in CDER and CBER.

The biologics center reviewers of Erbitux explained that they were careful not to give ImClone advance notice of their decision to refuse-to-file the BLA, preferring to communicate regulatory decisions exclusively through formal channels.

ImClone executives testified that they received no clear indication from CBER that a refuse-to-file action was under serious consideration.

Oncologic Drug Products Division Director Richard Pazdur, MD, in contrast, explained that it is his division's practice to alert sponsors in advance of an action to allow them the opportunity to withdraw the application (³ Also see "Erbitux Hearing Puts Focus On Pre-Approval Promotion, FDA Communication" - Pink Sheet, 17 June, 2002., p. 5).

ImClone's partner for Erbitux, Bristol-Myers Squibb, ultimately was able to determine that an RTF letter was imminent. The company used one of its consultants, who obtained the information from CDER.

One challenge for the agency in drafting the communications policy will be addressing two seemingly contradictory messages from the hearing.

Energy & Commerce Committee Chairman Billy Tauzin (R-La.) expressed concern about what he called the "leak" of information about the status of the Erbitux BLA.

Tauzin suggested that FDA should share some of the blame for the insider trading that may have occurred prior to formal release of the RTF letter.

However, Oversight Subcommittee Chairman Jim Greenwood (R-Penn.) declared that CDER's informal communication policy seems preferable to CBER's approach.

An early draft of the FDA communications policy is understood to advise limiting communication about regulatory decisions to formal action letters.

The early draft is understood to state that reviewers should not encourage sponsors to withdraw an application rather than face an adverse decision.

It also stresses that the final decision rests with the FDA official who has the authority to sign off on action letters.

The interim draft policy does not appear to have been widely circulated within FDA, but it has filtered down to some reviewers.

The agency is also addressing the Energy & Commerce Committee's concerns on a larger scale, via a plan to consolidate most biotech product reviews into CDER in the name of greater consistency (⁴ Also see "CDER Review “Consistency” Is One Theme Of FDA Reorganization" - Pink Sheet, 16 September, 2002., p. 13).

FDA Developing Reviewer Communications Policy; Draft Expected This Year

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