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FDA eyes drug testing flaws

FDA health officials' inspections have revealed serious flaws in drug testing done by a Canadian company that supported the applications of potentially hundreds of medicines currently awaiting federal approval or already marketed

FDA health officials' inspections have revealed serious flaws in drug testing done by a Canadian company that supported the applications of potentially hundreds of medicines currently awaiting federal approval or already marketed.

The FDA findings may mean that drug companies would need to either confirm or repeat tests undergone by their products to gain federal approval, according to FDA officials. While the work will not result in the removal of any drugs from the market, it could slow the approval of those drugs waiting for federal approval.

The FDA stressed it has no evidence of problems with the quality, purity or potency of the affected drugs, but it is sending more than 1,000 letters to pharma companies asking them to re-evaluate the results of test performed by MDS Pharma Services between 2000 and 2004 and included in applications to the FDA. The affected firms have six months for the re-evaluation process.

The FDA stressed that the request will only affect a small percentage of drug applications submitted since 2000.

Joseph Famulare, deputy director of the office of compliance in the FDA's drug evaluation and research division, said: "The FDA is taking this precautionary measure to make sure the data submitted to the agency are of the highest quality."

FDA inspections of two of MDS Pharma Services facilities in Canada showed a variety of problems with its testing procedures. The contract company, part of MDS Ontario, originally agreed to audit its own work, which failed to satisfy the FDA. The agency then appealed directly to drugmakers.

The FDA added that MDS Pharma Services failed to identify and eliminate sources of contamination in the tests, which measured drug levels in the blood of patients. MDS also failed to validate and document the accuracy of the testing methods it employed, said the FDA.

In response, MDS said it had taken numerous corrective actions to meet the FDA's requirements, but had not been able to fully satisfy the agency. The company planned to redirect efforts to support its clients with independent audit activities, it added.

Stephen P DeFalco, president and CEO of MDS, said: "While we are disappointed in the time and effort that it has taken to get this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve the issue. We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution."

In all, FDA officials have identified all 217 generic drugs that have either won or are seeking federal approval and that included MDS Pharma studies in their applications. For brand name drugs, the FDA is unsure as to which companies relied on testing done by MDS Pharma Services, so it will notify all brand-name drug makers that submitted more than 900 applications received since 2000 to search their files to discover which products are affected. The FDA declined to name the drug companies known to have contracted with MDS for testing services.

Shares of MDS fell more than two per cent to CAD 17.20 in afternoon trading on the New York Stock Exchange on 10 January, while its TSX shares also fell.

16th January 2007

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