The "Wall Street Journal" reports that the US Government Accountability Office, a Congress watchdog, is set to release a report today slamming the US Food and Drug Administration (FDA) for compromising its integrity. The report could lead to the cancellation of an FDA approval given to Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) competitors Novartis' AG's Sandoz Unit and Momenta Pharmaceutical's Inc. to sell the first generic version's of the Lovenox blood thinner.
On the day that the FDA gave approval to Sandoz and Momenta - July 23 2010 - Teva's share price fell 10%, because it was seen as paving the way for approval of a generic version of Teva's multiple sclerosis treatment Copaxone.
The Wall Street Journal writes that the FDA's actions will be condemned for "creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency."
The paper continued, "Teva officials told the Journal that the company met with the FDA in October and raised questions about possible bias. It has said its application, which was filed two years before Momenta's, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs."
"Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation. "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said."
"Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application," the "Wall Street Journal" added.
Published by Globes, Israel business news - www.globes-online.com - on November 9, 2010
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