FDA Eyes Drug Tests Done by Canadian Lab
Wednesday, January 10, 2007; 10:47 PM
WASHINGTON -- Health officials said Wednesday that inspections revealed serious concerns about drug testing done by a Canadian company that underpinned the applications of potentially hundreds of medicines pending federal approval or already on the market.
The concerns could compel some drug companies to either confirm or repeat certain tests their products underwent required to win federal approval, Food and Drug Administration officials said. While the work won't result in the removal of any drugs from the market, it could slow the approval of some drugs awaiting federal clearance.
The FDA stressed it has no evidence of problems with the quality, purity or potency of the affected drugs. Still, the agency is sending more than 1,000 letters to drug companies asking them to reevaluate the results of tests performed by MDS Pharma Services between 2000 and 2004 and included in their applications to the agency. Companies have six months to comply.
Ultimately, the request likely will affect only a small percentage of the drug applications submitted since 2000, FDA officials said.
"The FDA is taking this precautionary measure to make sure the data submitted to the agency is of the highest quality," said Joseph Famulare, deputy director of the office of compliance in the agency's drug evaluation and research division.
FDA inspections of two of MDS Pharma Services' facilities in Canada revealed a variety of problems with its testing procedures. The contract company, part of MDS Inc. of Mississauga, Ontario, originally agreed to audit its own work, but that failed to satisfy the FDA and prompted the agency to appeal directly to drug makers.
The FDA said MDS Pharma Services failed to identify and fix sources of contamination in the tests, which measured drug levels in the blood of patients. The company also failed to validate and document the accuracy of the testing methods it used, the FDA said.
In a statement, MDS Inc. said it has taken numerous corrective actions to meet the FDA's requirements but hadn't been able to fully satisfy the FDA. It planned to redirect efforts to support its clients with independent audit activities, the company said.
"While we are disappointed in the time and effort that it has taken to get to this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve this issue," said Stephen P. DeFalco, president and CEO of MDS Inc. "We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution."
Agency officials have identified all 217 generic drugs that either have won or are seeking federal approval and that included MDS Pharma studies in their applications. For brand-name drugs, FDA isn't as sure which companies relied on testing done by MDS Pharma Services. As a result, it is notifying all brand-name drug makers that submitted the more than 900 applications received since 2000 to comb through their files to find out.
The FDA declined to identify the drug companies known to have contracted with MDS for testing.
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