Pharmaceuticals and diagnostics firm Mayne Group Ltd (ASX:MAY) has received a highly critical warning letter from the US regulatory authority on Mayne’s reporting of adverse drug events (ADE) or suspected adverse patient reaction to medicines. But Mayne said today that it had already moved to satisfy the concerns expressed by the US Food and Drug Administration (FDA), which the company said did not relate to the quality of its drugs and would have no material impact on its 2005 financial results. The FDA’s letter of February 1, 2005, to the Mayne Pharma business in the US says an audit conducted from September to October 2004 at Mayne’s head office in New Jersey revealed that Mayne had violated US regulations on the reporting of and response to ADEs. Those violations included failing to submit ADE reports to the FDA in various cases. The FDA said the company had also submitted reports on some cases after the time required by the FDA, in one case involving morphine, 2,539 days late. Furthermore, Mayne had failed to conduct a follow-up investigation into “all serious and unexpected ADEs”. The FDA said, however, that it had received a response letter from Mayne dated November 3, 2004, and had completed a review of Mayne’s corrective actions. The FDA said it considered Mayne’s proposed corrective actions to be “adequate” even though it still had several questions regarding the company’s response.
