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PHARMAKINETICS' BIO SAMPLE LIBRARY UNDER REVIEW AS PART OF FDA GENERIC INVESTIGATION: QUESTIONS ON BOLAR's MELLARIL RAISED BY 1982 LETTER

Executive Summary

FDA has secured the retained samples and records from bioequivalence testing performed by PharmaKinetics for ANDA sponsors as part of the ongoing investigations into generic testing and data submissions to the agency. The Baltimore contract testing lab notes that because of its role as a third party contractor for many of the generic firms, its records have been identified as one of the sources of information for the investigation. "Our records and our unique policy of retaining test samples have been requested by various investigators so that they can gain a better insight into the generic drug industry," PharmaKinetics said in a Sept. 1 statement. The firm observed that "it is only natural that some of our records may be of interest." PharmaKinetics is a major outside contract testing firm for generic and brandname clients. The firm recently said that 57% of its client base was composed of generic manufacturers and 40% of its work was committed to the support of ANDAs. The company says it has worked on over 1,150 submissions to FDA during the last 13 years. FDA's access to those records provides a large hunting ground. PharmaKinetics is finding itself caught in the middle of the investigation. The firm is attempting to walk a tightrope of protecting client confidentiality while maintaining a reputation for reliability with FDA. In an apparent attempt to reassure clients about its confidentiality protections, the firm says that "during this investigation, there has been no disruption in the usual services we provide." Congressional investigators of the generic testing irregularities have mentioned increased controls over contract lab verification procedures and reporting requirements to FDA as potential changes which may derive from the investigations. One record from PharmaKinetics' files is drawing increased attention to Bolar's bio samples. According to published reports on a 1982 letter from PharmaKinetics to its client, the contract firm questioned the appearance of Sandoz Mellaril tablets in a bio sample from the generic manufacturer. PharmaKinetics says that the letter was supplied to FDA as part of the overall record hunt. Bolar responded to reports of the existence of the PharmaKinetics' letter by stating "the seven-year-old document referred to a product which was never developed, never tested, never sent to the FDA, and never marketed." Bolar charged "that the only purpose of releasing the letter at this time appears to be to increase pressure on the FDA to remove low cost generic Dyazide from the marketplace" (see story, p. 8). Bolar called the publicity about the letter "the latest in a series of inexplicable actions triggered by the Dingell Committee." Bolar's generic version of thioridazine received ANDA approval in late 1983. During the next two years, Sandoz complained in letters to the trade that certain versions of generic thioridazine did not match the blood levels of the orignator product. FDA criticized the trade letters as anti-generic and forced Sandoz to correct them. While PharmaKinetics attempts to maintain a distance from the investigations, there is an awkward twist for the firm in the continuing investigation of Bolar and its submissions to the contract lab. PharmaKinetics is widely believed to be Bolar's partner (through a technology license/royalty agreement) for the development of a generic version of diltiazem. That agreement may color the independence of the contractor/sponsor relationship between Bolar and PharmaKinetics in the eyes of some investigators. PharmaKinetics has at least four separate royalty/licensing agreements. The firm states "to the best of our knowledge," that it "is not the target of any suspected wrongdoing."

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