FDA faults drug studies by Pa. firm

January 11, 2007|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- Federal regulators said yesterday that they have found problems with a Philadelphia firm's studies of new medicines and that drug companies that hired it will have to re- evaluate test results.

MDS Pharma Services had been working with the Food and Drug Administration to address concerns about its testing at two Canadian facilities from 2000 to 2004, the FDA said. FDA officials said they were asking drugmakers to reconfirm results of MDS Pharma drug studies.

The FDA approved drugs partly on the basis of MDS Pharma test results that now have been called into question. However, FDA officials said they have detected no evidence of a safety risk.

Agency officials weren't certain how many drugs - either approved or awaiting approval - are involved. The FDA is sending out more than 1,100 letters to identify the drugs studied by MDS Pharma and have the results reviewed.

In the course of the investigation, FDA inspectors identified generic drugs whose testing was suspect, officials said. Manufacturers re-evaluated the drugs or repeated the tests and found that the medicines met standards, agency officials said.

FDA officials, who declined to identify the affected companies or drugs, expect similar findings for the remaining drugs.

"We expect there not to be major problems, but we are casting nets to cover all bases on this issue," said Joseph Famulare, deputy director of the FDA's drug compliance office.

MDS Pharma, a subsidiary of MDS Inc. of Toronto, did not respond immediately to a request for comment.

According to MDS Inc.'s most recent financial report, the company shifted 100 employees to review tests, hired a new president, suspended some testing at one of its facilities and changed its quality procedures. The effort cost $31 million last year, the report said.

Drugmakers often hire other companies to test new medicines. Another member of the $14 billion industry, SFBC International, came under scrutiny after a 2005 report of improper treatment of test subjects and potential compromises of test results.

MDS Pharma, one of the larger contract research organizations, was hired by drugmakers to measure the level of a new drug in a patient's blood. Such testing can be integral to the FDA's determination that a drug works safely.

Routine inspections of the MDS facilities in Montreal and Blainville from July 2003 to March 2006 found that contamination was not corrected, unexpected results were not investigated and that data might not have been reported accurately, according to FDA officials and agency documents.

Last year, inspectors reviewed MDS Pharma's response but issues remained, FDA officials said. The agency asked drugmakers to help them resolve the matter and gave them six months to conduct reviews.

jonathan.rockoff@baltsun.com

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