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Report Charges FDA Risked Integrity With Approval Of Generic

Wall Street Journal, Tuesday, November 9, 2010 10:40 AM

Alicia Mundy writes that a congressional committee plans to release a report by the Government Accountability Office today that says the Food and Drug Administration risked creating the appearance of favoritism toward Momenta Pharmaceuticals, a Boston company that won first rights to sell a the generic version of the blood thinner Lovenox after providing free consulting work to the agency.

"Agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," the report says.

Momenta provided free work for the FDA during its investigation of tainted Chinese drug imports in 2008. The FDA says it needed to draw on Momenta's expertise but admits it should have considered potential conflicts of interests and done more to disclose them. Momenta says it conducted the investigation for the FDA in the interest of public health.

Read the whole story at Wall Street Journal »

pharma, regulation

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