November 9, 2010 / 3:50 AM / 9 years ago

Watchdog to criticize FDA over generic drug approval: report

NEW YORK (Reuters) - A congressional committee is set to criticize the Food and Drug Administration for awarding a pharmaceutical company rights to sell a generic blood thinner after that company provided the FDA with free consulting work, the Wall Street Journal reported on Monday.

Momenta Pharmaceuticals, which won the first right in July to sell the generic version of Sanofi-Aventis’ blood thinner Lovenox, performed months of free work for the FDA in 2008, according to a report to be released on Tuesday by the Government Accountability Office, the newspaper said.

At the same time as Momenta was providing the consulting work, FDA officials were reviewing its application to sell its generic blood thinner, the Journal said.

The report will say that the FDA risked giving the appearance it compromised its integrity, said the WSJ, which reviewed a copy of the report.

The generic blood thinner is marketed by Momenta in partnership with Novartis AG’s Sandoz unit.

Momenta reported a better-than-expected quarterly profit earlier this month, helped in large part by the launch of the blood thinner.

Momenta, FDA and GAO officials could not immediately be reached for comment.

Reporting by Elinor Comlay; Editing by Lincoln Feast

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