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FDA FRAUD POLICY WILL NOT PENALIZE FIRMS FOR "WRONGFUL CONDUCT" BY SUBSIDIARIES; AGENCY WILL KEEP CLOSE TABS OF COMMONLY- OWNED FIRMS IN REGULATORY SITUATIONS

Executive Summary

FDA will not penalize corporations by suspending product reviews due to "wrongful conduct" by their subsidiaries, the agency told House Energy & Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.). Explaining FDA's fraud policy in a Feb. 12 letter, Deputy Associate Commissioner for Legislative Affairs Kay Holcombe said: "Although the agency considers relationships between corporations and corporate personnel in determining the need for and scope of validity assessments, wrongful conduct by one firm will not necessarily raise significant questions regarding the integrity of data in applications of a related firm." FDA's reference to considering the relationship between firms and corporate personnel suggests that the agency will be vigilant in its efforts to avoid accepting marketing applications from a front or shell company established by a corrupt corporation or its executive. Holcombe was responding to a series of questions Dingell asked in a Nov. 13 letter to the agency. Among other things, the Michigan Democrat inquired whether reviews of Pfizer NDAs for innovative new compounds would be delayed due to difficulties FDA experienced with the firm's Shiley medical device subsidiary ("The Pink Sheet" Nov. 25, p. 6). At that point, Pfizer had at least one NDA in the final stages of FDA review: Zoloft (sertraline). That product was subsequently approved on Dec. 30. The agency replied that its Center for Drug Evaluation and Research "has not requested validity assessments of NDAs submitted by Pfizer because currently available evidence does not indicate that Pfizer's NDAs have been affected by Shiley's activities." FDA also indicated that it will not slow reviews of potentially life-saving new treatments even if their sponsors otherwise are subject to sanctions under the fraud policy. Dingell was concerned that if FDA's policy is broad in scope, important new therapies from suspect innovator companies will be kept off the market while the firms undergo "validity assessments" to confirm the reliability of their data submissions. "The fraud policy does not preclude FDA from conducting a substantive scientific review of an application that is simultaneously being subjected to a validity assessment" under the fraud policy, Holcombe wrote. "Generally, we would not suspend review of an application of a drug product that is considered in some way innovative and which may provide a medically important advantage over already marketed products." Under the agency's former A,B,C system for rating the therapeutic gains of new drugs, FDA "ordinarily...would have deferred review of C-rated applications," the letter states. CDER "generally would have expected not to defer substantive data review pending validity assessments of A and B-rated applications because of the therapeutic significance of the drugs," the letter states. Under the simplified priority/standard review rating system established Jan. 1 at the recommendation of the President's Council on Competitiveness ("The Pink Sheet" Jan. 13, In Brief), it is not clear how FDA will distinguish among S-rated applications, that is, all drugs but those for life-threatening or debilitating illnesses for which there is no alternative adequate therapy. However, FDA said all NDAs "subjected to validity assessments under the fraud policy" to date "have been for products identical in molecular entity, dosage strength, route of administration and indication to already marketed products." The agency said it has suspended reviews of three pending NDAs submitted by Bolar. "All three NDAs have an S-rated review priority in the current NDA rating system and had a C-rated review priority in the system used by CDER prior to January 1992," Holcombe explained. "Substantive scientific reviews of those NDAs have been suspended, pending completion of the validity assessment described in the fraud policy." Dingell had inquired how FDA would handle Bolar NDAs or applications to which Bolar contributed supporting data.
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