US FDA urges drugmakers and pharmaceutical companies to check their clinical studies data for certain drugs 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 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.
Worldwide drug authorities require that prescription and over-the-counter drugs, food additives, and food substitutes be thoroughly tested before being marketed. Many personal care products, such as sunscreens and cosmetics, need human testing as well. MDS Pharma Services conducts this type of research, gathering scientific data that verifies a new product’s safety and substantiating the types of claims that can be made.