Washington Editor

WASHINGTON - Hundreds of drug companies soon will receive requests from the FDA to find out whether MDS Pharma Services generated pharmacokinetic data for them between 2000 and 2004.

If so, the tests might have to be redone, because the findings could be wrong.

The agency's concerns are focused on "the conduct of the laboratory analysis of these tests," said Joseph Famulare, the FDA's deputy director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) during a conference call held Wednesday. "These are studies designed to identify and describe the absorption, distribution, metabolism and excretion of drugs in humans."

The agency uncovered problems during routine inspections of two MDS Pharma sites in Canada, glitches that included inaccurate drug level data, failures to investigate unexpected values and a lack of reproducible findings.

Such data are sometimes included in approval applications for new and generic drugs. And while Famulare said that patients who use products affected by this action "are not believed to be at any increased safety risk," the FDA wants to confirm that data used in making approval decisions are "of the highest quality."

Brand-name drugmakers are being asked to review their applications for currently marketed products to identify MDS Pharma-conducted pharmacokinetic studies between 2000 and 2004. The agency also is mining its internal databases for the same information, in addition to examining whether some pending new drug applications might include such questionable reports. With regard to the latter, it could take longer for currently filed submissions to get approved.

Once pharmacokinetic data in question are identified, the FDA will assess "what, if any, further action needs to be taken," Famulare said. When necessary, the FDA will work with affected companies to ensure that they validate their findings through audits, new analyses or repeating their tests. "That will help serve to determine the validity of the data that we have and resolve the issues," he said.

Famulare told BioWorld Today that costs for re-examining these findings or redoing the studies represent "a variable," depending on which avenue a company must take. But he conceded that repeating pharmacokinetic work probably would be the costliest and most time-consuming action.

Of note, the market research firm Frost & Sullivan estimated that contract research businesses collectively earned about $7.5 billion last year, and about 15 percent of that aggregate comes from patient monitoring activities that include pharmacokinetic testing.

John Jenkins, the director of CDER's Office of New Drugs, said the agency would send more than 900 letters to drugmakers regarding approved products in the five-year period in question. The number of companies involved is less than that, and those affected in the end will be even smaller. But he said this "very comprehensive search strategy" is necessary to cast "a broad net" because the FDA does "not have a specific count of the number of applications that have been approved during the time period that we're focusing on."

The agency's generic drug division is sending out more than 200 letters.

Drugmakers have six months to respond.

MDS Pharma, of King of Prussia, Pa., offers a wide spectrum of drug discovery and development services, from early stage activities such as lead optimization to late-stage studies between Phase IIb and IV.

Famulare, who said the agency has not been satisfied with MDS Pharma's proposal to ameliorate the situation through a five-year, retrospective audit, indicated that the company's accounts from past contract work have been used in identifying pharmacokinetic data relevant to this investigation. Its drugmaking clients include a veritable roster of the biotech and pharmaceutical industries, according to its website.

An MDS Pharma spokesperson declined to comment on the news. The business is a unit of MDS Inc., a Mississauga, Ontario-based firm whose shares (NYSE:MDZ) gained a penny Wednesday, to close at $17.63.