U.S. urges drugmakers to check some data from MDS

January 10, 2007
AmericanScientific.com
By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials urged dozens of generic drug makers on Wednesday to confirm or repeat some studies done for them by a unit of MDS Inc. to make sure the results were accurate.

Inspections of two MDS Pharma Services sites in Canada raised questions about the validity and accuracy of studies conducted from 2000 to 2004 to measure drug levels in a patient's blood, the U.S. Food and Drug Administration said.

The studies may have been part of the basis for FDA approval of generic or brand-name drugs. A total of 140 approved generic applications and 77 pending applications used such data from MDS, FDA officials said. They were submitted by 52 generic drug makers.

The agency said it had not seen any signs that drugs tested by MDS posed a safety risk, and had no evidence of any problems with quality, purity or potency.

"FDA is taking this action as a precautionary measure to ensure that data submitted to the agency and used in making approval decisions is of the highest quality," an agency statement said.

The agency "believes all the drugs involved continue to be safe and effective," said Joseph Famulare, deputy compliance director in the FDA's Center for Drug Evaluation and Research,

Officials have not yet identified how many brand-name drugs may have been affected. The agency is asking sponsors of more than 900 brand-name drug applications approved since 2000 to check if they used MDS data. Only a very small subset were expected to have included the company's research, said Dr. John Jenkins, director of the FDA's Office of New Drugs.

Testing blood levels of drugs is a key for determining if a generic copy is equivalent to a brand-name version.

Pending generic applications that had included MDS data could take a bit longer to win approval while findings are confirmed, said Gary Buehler, director of the FDA's Office of Generic Drugs.

EFFICIENT 'PATH TO CLOSURE'

Shares of Toronto-based MDS Inc. closed up 3 cents to $17.63 on the New York Stock Exchange after earlier falling more than 2 percent, while its shares on the Toronto Exchange lost 21 Canadian cents lower to close at C$20.47.

In a statement late Wednesday, MDS called the FDA action "an efficient path to bring closure" to the agency's probe of the studies, which dates back to 2004.

"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 MDS President and Chief Executive Stephen DeFalco.

The company said it would end its own review of the studies and redirect efforts to help clients with independent audits.

Industry analysts said the FDA action was expected, as the company had said the firms it contracted with would need to reassess their data.

"It's not going to help these guys win contracts, but it's not something we didn't largely know about," said Brian Bapty, biotech analyst at Raymond James Ltd.

In 2004, the agency chastised MDS in a letter detailing a number of concerns about its Montreal-based bioanalytical business.

They included MDS's failure to conduct a thorough and systematic evaluation of contamination that occurred during a study sample analysis.