Faulty and Contaminated Tests Could Affect Drugs Approved by FDA from 2000 to 2004
The U.S. Food and Drug Administration (FDA) is sending more than 1,000 letters to pharmaceutical companies asking them to reevaluate the results of tests performed by MDS Pharma Services between 2000 and 2004 that were part of applications for approvals from the FDA. The drug companies have six months to comply. The agency said that the request likely will affect only a small percentage of the drug applications submitted since 2000.
MDS Pharma Services is a laboratory testing facility located in Canada that is operated by MDS Inc., calling itself a “global life sciences company”, doesn’t produce pharmaceuticals but provides products and services for the development of drugs and the management of disease.
Headquartered in Toronto, Ontario, Canada, MDS is the largest operator of clinical laboratories in Canada. More than half of the company’s revenue is generated in other locations throughout the world, mostly in the U.S. and Europe. MDS generated about $1.5 billion in revenues in the 2006 fiscal year.
FDA inspections of two of MDS Pharma Services’ facilities in Canada revealed a variety of problems with its testing procedures. The company 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 failed to identify and correct sources of contamination in blood tests that measure drug levels, and failed to validate and document the accuracy of its testing methods.
Cannot identify all affected drugs
Although the FDA says it identified 217 generic drugs tested by MDS that have been approved or are waiting for approval, the agency cannot name (or failed to name) which companies relied on MDS tests for brand-name drugs. The FDA openly declined to identify drug companies known to have contracted with MDS for testing.
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 what drugs were tested at MDS. The FDA tried to assure the media that it has no evidence of problems with the quality, purity or potency of the affected drugs. And it said the work will not result in the removal of any drugs from the market, but it could slow the approval of some drugs awaiting federal clearance.