Opinion ID: 688698
Heading Depth: 3
Heading Rank: 1

Heading: Vancomycin

Text: 3 In 1987, Quad submitted an abbreviated new drug application (ANDA) to the FDA in an attempt to obtain that agency's approval to market vancomycin, an injectable antibiotic. See 21 C.F.R. Secs. 314.2, 314.55 (1987). In order to gain approval, FDA guidelines required, inter alia, the submission of stability data from three different research batches of the drug. See Center for Drugs & Biologics, Food & Drug Admin., U.S. Dep't of Health & Human Servs., Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics 25-26 (Feb.1987). A batch is defined as: 4 a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. 5 Id. at 3 (quoting 21 C.F.R. Sec. 210.3(b)(2)). 6 The batch process for vancomycin is relatively simple. Powdered vancomycin, purchased from an FDA-approved supplier, is tested and weighed. Water is then added to make 10 liters of a vancomycin solution, which is placed into vials and freeze-dried in a process known as lyophilization. The resulting sterile powder is tested for stability, and the data is submitted to the FDA as a batch record. 7 Chatterji's participation in the conspiracy as related to vancomycin consisted of the following. Chatterji first prepared 10 liters of vancomycin solution, which he then divided into two fill sizes of 10 ml and 5 ml labeled as 488A and 488B. Because the separate fill sizes were portions of the same batch, they were lots as defined by the FDA. See id. at 5. 3 He then lyophilized the contents of each vial and tested the resulting powder. Further, because he had exhausted Quad's supply of powdered vancomycin in producing lots 488A and 488B, Chatterji did not have unprocessed vancomycin immediately available to create another batch. Rather than suffer the delay and expense of obtaining additional unprocessed vancomycin, Chatterji reconstituted the remaining lyophilized vancomycin from lots 488A and 488B, divided it again into two separate fill sizes labeled 495A and 495B, and lyophilized and tested them. 4 Rather than skewing the test results in Quad's favor, Chatterji's use of reprocessed vancomycin had the potential to make the substance used for the test less stable and hence less likely to meet FDA standards. 8 Chatterji then forwarded these test results to Dilip Shah, Quad's head of regulatory affairs, who submitted Quad's ANDA for vancomycin claiming that 488A and 488B were separate batches and failing to reveal to the FDA that 495A had been made with reprocessed vancomycin. Therefore, when submitted, Quad's ANDA for vancomycin included records for three purported batches, when in fact only one acceptable batch had been produced. Although it was not required to do so, Quad later prepared and tested another batch of vancomycin and forwarded the results to the FDA. 9 The FDA subsequently approved Quad's marketing of vancomycin based on the records for lots 488A, 488B, and 495A, as well as the later-submitted record. Thus, the FDA's approval was based on two valid batch records. Repeated tests of vancomycin produced by Quad after FDA approval revealed that in every instance the drug met all FDA requirements for safety and effectiveness. Indeed, the Government does not dispute that Quad's vancomycin had full therapeutic value and posed no danger to consumers. Quad's gross sales of vancomycin totalled approximately $8 million.