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REP. DINGELL's SUBCOMMITTEE PURSUES Ex-FDA OFFICIAL NORRIS: INCONSISTENT TESTIMONY

Executive Summary

REP. DINGELL's SUBCOMMITTEE PURSUES Ex-FDA OFFICIAL NORRIS: INCONSISTENT TESTIMONY at an Oct. 15 hearing before Dingell's (D- Mich.) Energy & Commerce/Oversight subcommittee will be the subject of continued inquiry by the Hill panel, acting subcommittee chairman Rep. Wyden (D-Ore.) said after a Dec. 20 hearing that evaluated Norris' earlier testimony. "Our investigation into possibly arbitrary action at FDA . . . including Mr. Norris' knowledge thereof, is going to continue," Wyden said. On Oct. 15, Norris appeared before the subcommittee to describe his relationship with Barr Labs in his capacity as an exec VP at the public relations firm Hill & Knowlton ("The Pink Sheet" Oct. 22, p. 9). The subcommittee has been investigating possible retaliation by FDA against Barr Labs because of the generic firm's role in uncovering the generic scandal and the company's aggressive challenge of FDA actions. Norris was hired by Barr to look into possible biases within the agency. When his report to Barr seemed to confirm the existence of a bias at FDA, the subcommittee asked to hear Norris' testimony on the subject. Norris declined to testify until the subcommittee issued a subpoena. The Dec. 20 follow-up hearing was convened to examine inconsistencies in Norris' Oct. 15 testimony. Dingell's opening statement, read by Wyden, said that Norris' "recollection of his conversation with the one 'key official' at FDA (rather than the several officials previously claimed in communications with Barr), as reported in his letter and attachment to Barr, appeared overblown at best." In addition, "his failure to recall reporting to Barr that it was viewed by FDA as 'corrupt' and one of the 'three worst companies' regulated by FDA required further inquiry," Dingell stated. Appearing before the committee were FDA Planning and Management Communications Staff Director Robert Navazio -- the one "key official" Norris named as a contact within FDA -- and a panel of five attorneys representing Barr Labs, led by Barr General Counsel Kip Schwartz. Norris is apparently becoming a pawn in the continuing fights between Barr and FDA and the Dingell subcommittee and FDA. Testimony from Navazio suggested that Norris may not only have exaggerated the number of FDA officials with whom he conferred but also may have misrepresented the nature of the information he received in these discussions. In an Aug. 29 letter to Barr, Norris stated that his FDA contacts had informed him "that Barr's relationships with FDA have deteriorated substantially in the last several months. Although good relations do not guarantee approvals, bad relations do guarantee delays." In a meeting with the five Barr attorneys on Aug. 9, Norris also said that Barr was regarded by agency officials as "sleazy," "corrupt," "scientifically unscrupulous" and one of the "three worst companies" reviewed by FDA, according to Schwartz. Navazio denied ever making such comments to Norris in either a formal or informal context. He said that his remarks to Norris were limited to a statement "that there were strong and longstanding scientific disputes" between the generics firm and federal authorities. Schwartz testified that Barr was asked to pay Hill & Knowlton, the public relations firm with which Norris worked, "something in the neighborhood of $ 8,000 per month" for an "intelligence gathering campaign." The campaign was designed to discover FDAers with a bad opinion of the firm.
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