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McNEIL's DESI DEFENSE OF PARAFON-FORTE CUT INTO FDA REVIEW TIME

Executive Summary

McNEIL's DESI DEFENSE OF PARAFON-FORTE CUT INTO FDA REVIEW TIME for other NDAs for non-steroidal anti-inflammatories and pain products, several agency officials suggested at a June 19 meeting with Johnson & Johnson CEO James Burke. According to an FDA memo of the meeting, J&J requested the meeting on the general topic of "how the review process operates." The memo said Burke discussed problems J&J had had "with Tylenol and Zomax that had been very costly and thus increased the importance of getting new products approved by FDA." The memo said Burke "eventually got around to asking why there was so much delay in getting products approved" in the Oncology & Radiopharmaceutical Div. -- - which handles NSAIDs and pain products as well as cancer and in vivo diagnostics. According to the FDA memo, Office of Drug Research and Review Program Management Deputy Richard Terselic told J&J that the company's "pursuance of the defense of Parafon-Forte was an example" in his opinion "of a highly costly and limited success potential advocacy by J&J that cut into the time available for review of their NDAs." The company has been contesting the proposed NDA withdrawal of the DESI "less than effective" drug. FDAer John Harter, MD, was reported by the memo as saying that "a more than normal percentage of the total time of his group was spent on J&J issues when you consider" the firm's INDs/NDAs, legal challenge to OTC ibuprofen, and Parafon Forte. Burke met with Com. Young less than a year ago to discuss the status of Zomax and the nonsteroidal anti-inflammatory Suprol, for which an NDA is pending ("The Pink Sheet" Sept. 24, "In Brief"). The memo said that Harter "characterized his experience with the J&J firms as providing a substantial basis for a lack of trust or confidence in what they submit." The memo reported that Burke said "that if he found that Dr. Harter was correct that he would see to changes in people and process as were appropriate." The FDA memo observed that Harter was expressing his own personal opinion of J&J's relations with the agency. In addition, the memo noted that Harter "identified Mr. Pat Seay [PhD], as an example of a person in J&J who he had found was entirely trustworthy and keenly aware of, and successful, in providing exactly what Dr. Harter needed for his reviews." In February, Seay was moved from exec director of regulatory affairs of McNeil to senior regulatory affairs liaison, a position which allows Seay to concentrate on the company's links to Washington. According to the memo, FDAers suggested that Burke "consider establishing one or more independent IRB-type groups in J&J to screen important submissions intended to come to FDA as a means of assuring that competitive business pressures did not compromise the objectivity of their submissions or, more simply, that the type of quality Mr. Burke wanted to see demonstrated on the part of J&J firms was in fact the case."

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