November 8, 2010
By ALICIA MUNDY
WASHINGTON—Congress’s watchdog arm has criticized the Food and Drug Administration 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.
On Tuesday, a congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG’s Sandoz unit.
Also critical of the FDA’s actions are Momenta’s rivals—including Teva Pharmaceutical Industries Ltd., the world’s largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA’s generic-drug division. The drug companies’ applications are still awaiting FDA action.
The controversy centers around Momenta’s performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company’s application to sell the generic version of a blockbuster blood thinner.