FDA Must Hand Over Vioxx Documents To Lawyer

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documents2.jpgA federal judge refused to grant the agency’s request to delay turning over Vioxx documents that were requested by a lawyer who reps about 300 people in lawsuits in which they claim they were harmed by Merck’s withdrawn painkiller.

In a ruling, US District Court Judge Faith Hochberg decided to appoint a mediator to create a process for deciding which documents can be turned over to Eric Weinberg. Last April, he filed a lawsuit against the FDA after the agency failed to provide documents or offered incomplete files in response to 10 Freedom of Information requests he made between October 2004 and August 2006. Weinberg, who accused the FDA of unreasonable delays, is seeking Vioxx media ads, the personal calender and other info from former FDA chief counsel Dan Troy, and communications between the agency and Merck. (Here is the order).

“This means the FDA may have to produce documents (that could reveal information) about Merck’s relationships with the FDA,” Weinberg tells Pharmalot this morning. Among the info he is seeking are documents to verify that Peter Honig, a former director of the FDA’s Office of Drug Safety, who joined Merck in February 2002 as vp of risk management, sequestered himself from decisions regarding Vioxx label warnings while he was talking to Merck about the job. The FDA sought a warning label but Merck fought that effort and it took two years before a warning was added.

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  1. Ed you’ve written another piece with added supporting evidence that the FDA just doesn’t get it these days.

    I read the Court’s Order and it clearly shows, according to the Judge signing the Order, that the FDA has had a steady and continuing decline in FOIA requests, yet, the FDA continues to NOT produce the documents requested.

    It is my belief that this Court’s Order will be valuable to and enhace the ability of CareToLive in their suit against the FDA in the Provenge matter in providing more precedence for the FDA to put-out, as it is, in producing the FOIA documents.

    Thank You! for continuing to bring the FDA’s inappropriate actions to the public’s attention. Hopefully, you’re archiving your columns in order to prepare and use them in YOUR upcoming book, I’m sure you are/will write on this topic.

    Keep up the investigation and your reporting on this!

  2. [...] sued the FDA to force the agency to produce documents under the Freedom of Information Act. Pharmalot reports that Weinberg filed 10 FOIA requests between October 2004 and August 2006 seeking “Vioxx [...]

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