FDA: DRUGMAKERS SHOULD REVIEW STUDIES CONDUCTED BY MDS PHARMA
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
During inspections of two of the company's Canadian facilities beginning in July 2003, the FDA found data that raised doubts about the accuracy of the company's study results from 2000 to 2004. MDS performs pharmacokinetic studies that measure the drug levels in patients' blood. Drug companies include these studies in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) when seeking FDA approval for their products.
MDS agreed to conduct an audit of its data, but the agency then found deficiencies with the audit. Now, the FDA is taking action and sending letters to companies whose approved and pending applications may include MDS studies, the agency said Jan. 10.
Joseph Famulare, deputy director at the agency's Office of Compliance, said all the affected drugs remain safe and effective, and the agency has no evidence that patients are at risk. Still, the agency has sent the letters asking companies to reaffirm results from the faulty MDS tests.
In the letters to sponsors, which the FDA posted on its website, the agency said problems with the MDS studies included:
Failure to conduct a thorough evaluation to identify and correct contamination sources;
Failure to investigate anomalous results;
Lack of assay reproducibility between original and repeat results;
Assay accuracy that was not assured under the conditions of sample processing;
Biased manipulation of study data resulting in the acceptance of failed runs; and
Failure to demonstrate the accuracy of analytical methods with appropriate validation experiments and documentation.
The letters asked the companies to reevaluate the lab results by repeating the studies, reassaying the study samples at a different facility or commissioning an independent expert to conduct an audit of the MDS test results.
Instructions for generic companies varied from those for brand companies, Famulare said. The letter asked generic companies to reevaluate lab work and results from currently marketed products and pending ANDAs within six months, he said.
Samples of the agency's letters can be viewed at www.fda.gov/cder/news/pharmaco_studies/pending.pdf (http://www.fda.gov/cder/news/pharmaco_studies/pending.pdf) and www.fda.gov/cder/news/pharmaco_studies/approved.pdf (http://www.fda.gov/cder/news/pharmaco_studies/approved.pdf).