Judge denies FDA request on Vioxx document delay

WASHINGTON U.S. District Court for the District of New Jersey Judge Faith Hochberg has denied the Food and Drug Administration’s request to delay turning over documents relating to Merck’s painkiller drug Vioxx.

 

A lawyer, Eric Weinberg, requested the documents under the Freedom of Information Act. Weinberg made 10 requests between October 2004 and August 2006 and according to him, the FDA did respond to five requests, did not produce all documents for three of the requests in a timely manner and did not produce documents for two requests.

 

 

Weinberg requested information including clinical trial data, adverse event reports, Vioxx advertisements, and correspondence between the FDA and Merck regarding the drug.

 

 

The FDA told Weinberg its responses were delayed due to a backlog of Vioxx-related requests. Agencies have 20 days to determine whether to comply with an FOIA request.

 

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