6:25 AM
Feb 22, 2019
 |  BC Extra  |  Politics & Policy

FDA rebuts allegations that imported generics are unsafe

FDA punched back Friday against news media stories that accused the agency of lax oversight of generic drugs manufactured in India and China.

In a statement, FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock summarized the findings of a team that investigated allegations made by Bloomberg News that the agency is exposing Americans to unsafe or ineffective generic drugs. The statement does not mention Bloomberg, but Gottlieb and Woodcock wrote that they are “directly responding to a news report.” The issues they address were raised in a Bloomberg story published on Jan. 31.

“We stand by our reporting,” a Bloomberg spokesperson told BioCentury.

The Bloomberg story asserted that poor...

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