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BARR’s REGULATORY STATUS WITH FDA TRIGGERS ANOTHER HOUSE HEARING ON OCT. 15: EX-DEPUTY COM. NORRIS TESTIFIES ON HILL & KNOWLTON FDA RELATIONS PLAN

Executive Summary

The House Oversight Subcommittee is continuing to pursue the question of regulatory retaliation by FDA against Barr Labs for that firm's role as a whistleblower in the generic drug investigations. At an Oct. 15 hearing, the subcommittee questioned former FDA Deputy Commissioner John Norris about a recent letter that he wrote to the company which implied potential agency retribution against Barr. In an Aug. 29 letter, Norris told Barr: "Although good relations do not guarantee approvals, bad relations do guarantee delays." "The subcommittee is very concerned that Mr. Norris, a former FDA deputy commissioner, would allege that his agency historically arbitrarily and capriciously punishes firms" that exhibit "belligerence" in their relations with FDA, said Rep. Wyden (D-Ore.), who chaired the hearing. Wyden handled the hearing as a stand-in for Subcommittee Chairman Dingell (D-Mich.). Wyden based his concern on the Aug. 29 Norris letter. Barr had contacted Norris in his current capacity as executive VP of the public relations firm Hill & Knowlton for help in improving the manufacturer's relationship with FDA. The former FDA senior official told Barr that he had been informed by "key individuals at FDA...that Barr's relationships with FDA have deteriorated substantially over the past several months." Pressed during the hearing, Norris identified the "key individuals" at the agency with whom he had spoken as one person, Robert Navazio, who was executive secretariat when Norris was deputy commissioner. The term in the letter to Barr is plural, Norris explained, to indicate that Navazio was reflecting the opinion of "several" FDA officials who believed that Barr's relationships with FDA had deteriorated. Barr has complained repeatedly and widely within Washington about FDA's treatment of the firm since it took its allegations against FDA's generic review processes to Capitol Hill ("The Pink Sheet," April 30, p. 5). To help counter any ill will at FDA, the firm apparently approached Hill & Knowlton for help in designing an image-improvement campaign. In April, Barr complained that it had not received any ANDA approvals since the beginning of the generics investigations in 1988. The firm has received at least three ANDAs since that complaint, including a potentially significant first ANDA clearance for oncologic uses of methotrexate on Oct. 16. Wyden maintained that the response by Norris to Barr and the accompanying draft proposal for an "FDA relations action plan" suggest that FDA's ANDA review process is "arbitrary and capricious," that FDA reviewers are "not sufficiently professional to put aside their emotions" when considering a marketing application, and that criteria for approval include something besides scientific evidence of safety and efficacy. The Oregon Democrat said it is "unfortunate" that "you have to have a high-priced public relations [program] or you're not going to get a fair shot at FDA." Norris replied that he believes FDA's science is "impeccable." He pointed out that his letter urges Barr "to rebuild your working relationships with FDA as ones based on real and perceived integrity and mutual trust and respect." Norris was caught in a difficult position at the Oct. 15 hearing: between being goaded into implications about FDA's lack of objectivity and drawing criticism for his contact with FDA as a consultant working outside the agency. Norris was reluctant to answer questions about other client pharmaceutical manufacturers that might have sought help in improving FDA relations. His Sept. 28 letter to the subcommittee states that he was "advised by Hill & Knowlton's counsel that a request for client lists raises sensitive issues respecting proprietary and trade secret information, the disclosure of which could subject Hill & Knowlton to liability from its clients." Before the hearing, Norris emphasized that he made no improper contacts with FDA as former deputy commissioner on the behalf of clients. In a Sept. 28 letter to the subcommittee, Norris said he did "not recall making any professional contacts or having professional conversations on behalf of clients with FDA" during the first two years after he left the agency. Norris also testified that Barr had contacted him. He maintained that he had attempted to excuse himself and Hill & Knowlton from implementing the draft action plan due to concerns about a potential conflict of interest. The subcommittee criticized Norris for not being more cooperative with its investigation. Wyden said the subcommittee "regrets" that on Oct. 8 it had to issue a subpoena for Norris to testify. The former deputy commissioner "was granted ample opportunity to appear voluntarily for an interview by the staff and to present his written explanation of the" letter and draft plan, Wyden noted. Norris testified that he was "surprised to hear that the subcommittee found [his] fully cooperative posture unsatisfactory." He noted that he supplied written answers to subcommittee questions "several weeks ago," and he "appeared here at the appointed day and time" when asked to supply oral testimony.
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