'Congressional watchdog says FDA favored Teva competitors'

'Wall Street Journal' say US Government Accountability Office set to release report suggesting bias.

By YAEL GRUNTMAN
Teva Pharmaceutical Industries. (photo credit: Ariel Jerozolimski)
Teva Pharmaceutical Industries.
(photo credit: Ariel Jerozolimski)
The US Government Accountability Office, a Congressional watchdog, is set to release a report slamming the US Food and Drug Administration for compromising its integrity by favoring competitors of Teva Pharmaceutical Industries Ltd., The Wall Street Journal reported Monday. The report could lead to the cancellation of FDA approval given to Novartis’s AG’s Sandoz Unit and Momenta Pharmaceutical Inc. to sell the first generic version’s of the Lovenox blood thinner.
The FDA gave approval to Sandoz and Momenta on July 23.
Teva’s share price fell 10 percent the same day, because it was seen as paving the way for approval of a generic version of Teva’s multiple sclerosis treatment Copaxone.
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 Journal report said.
“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,” the report said.
Richard Adams, a former official in the FDA’s generic-drug division who retired this year, agreed with the bias allegation, the report said.
“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 Journal report said.


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