MDS Pharma ends FDA probe nightmare
Canadian operations by putting an end to some activities at its
Montreal facility, cutting 160 jobs.
The decision comes only three months after MDS undertook a similar scale-back process with its Quebec City plant. The contract research organisation (CRO) will cease drug metabolism and pharmacokinetics (DMPK) operations in Montreal by the end of August, eliminating around 40 positions, company spokesperson Charlene McGrady told Outsourcing-Pharma.com. The liquid chromatography mass spectrometry (LC/MS) unit will also be affected as the Montreal site will not restart commercial operations, which were halted in 2005. The LC/MS unit is expected to close by the end of October, getting rid of around 100 staff, said McGrady. In addition, the organic chemistry operations will stop at the same time as the LC/MS ones, cutting an additional 20 jobs. The reorganisation means that the St Laurent facility will focus on its bioanalytical ligand binding testing services, Phase I clinical operations, pharmacodynamics and pharmacokinetics testing, and late stage clinical trial management, said McGrady. She added that the move was driven by client demand and would enable the Montreal site to centre on the "future and promising growth areas". This consolidation represents a closure for the company and puts an end to years of crisis for MDS Pharma that started when US Food and Drug Administration (FDA) inspections of the company's two Canadian plants in 2003 found a range of problems with its pharmacokinetics testing procedures, including failure to identify and fix sources of contamination in bioanalytical tests, which measured drug levels in the blood of patients. As a result, the FDA began a review in February 2005 of all the bioequivalence tests performed by the pharma services unit of MDS between 2000 and 2004, and in September last year, MDS voluntarily suspended its LC/MS services in order to undertake its own internal review. In January this year, the FDA finally clarified a path for MDS' bioanalytical clients to "provide a route for closure" to the agency's review. As part of the final stages of the regulatory action, the FDA has given MDS' clients until June to take one of the three following actions: repeat their bioequivalence studies, re-analyse their original study samples at a different bioanalytical facility, or independently audit original study results. According to the FDA, more than 1,000 brand-name and generic drugs that have been approved or submitted for approval since 2000 may have included MDS data in their applications. While this will not result in the removal of any drugs from the market, it could delay approval of pending drug applications. The FDA stressed that the retesting was only a precautionary measure and it also made clear that it did not have any evidence that there were problems with the quality, purity, or potency of the affected drug products. Commenting on the St Laurent's site consolidation, MDS Pharma president David Spaight said: "These actions bring closure to the past and clarity to the Montreal site's future direction." "Investments will be made there over the next several months to create a new and more appropriate facilities footprint for the site." McGrady added that while the firm's North American preclinical DMPK operations will be consolidated in Bothell, Washington, and its North American bioanalytical LC/MS testing will be consolidated in Lincoln, Nebraska, no disruption in client service is expected to result from this reorganisation.
