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Raising the yellow flag
February 2007
by Jeffrey Bouley  |  Email the author


KING OF PRUSSIA, Pa.—In early January, the FDA issued more than 1,000 notification letters to various pharmaceutical companies recommending that they reevaluate pharmacokinetic studies that were conducted for them by MDS Pharma Services at its St. Laurent and Blainville, Quebec sites in Canada from 2000 through 2004. Some drug companies may be required to confirm or repeat certain tests already applied to their products to win federal approval. As such, the approval of some drugs awaiting federal clearance may be slowed down, though the FDA has said no drugs that have already received approval will be taken off the market. "It is important to emphasize that this action does not apply to any of our other sites or work conducted outside this time period," notes Stephen DeFalco, president and CEO of MDS Inc., parent company of MDS Pharma Services. "We are redirecting our efforts from conducting assessments in the five-year review to supporting our customers with our independent audit activities. We have had sponsors already complete audits and are working with others to schedule audits. We understand from sponsors that specific clients who have already conducted audits have received approvals based on that work." Also, both the FDA and MDS are stressing that this federal notification is a precautionary measure only and that no evidence has been found of actual problems with the quality, purity or potency of the affected drugs—only concerns over the testing procedures. MDS has been working with the FDA on this concern over tests at the two facilities since 2004. MDS initially agreed to undertake a comprehensive self-review of bioequivalence studies conducted at its St. Laurent facility from 2000 through 2004 and after that, the FDA conducted an inspection of MDS Pharma's bioequivalence operations in St. Laurent and Blainville during March 2006. In September 2006, the FDA sent MDS Pharma a letter that was critical of the management and the effectiveness of the retrospective review and expressed the feeling that their concerns had not been fully addressed. As of the fourth quarter 2006, MDS Pharma reported that it was continuing to devote "substantial effort and resources" in the conduct of the retrospective review, and noted that it has incurred direct costs of $10 million in that quarter as a result. Full year costs for 2006 regarding the testing issue were $31 million, including direct labor, consulting costs, and the cost of related customer accommodations. DeFalco commended the FDA for developing a "practical and efficient path" for closure of the review of bioanalytical studies conducted at the Quebec facilities, a path that includes three options for MDS customers: redoing the studies, reanalyzing the samples or conducting an independent audit of the data. "We remain committed to working with the agency and our customers to bring final closure to this issue," DeFalco says. 
Code: E020718



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