Comments on: Vioxx Lawyer Sues FDA Over FOIA Requests http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/ News, Comment and Conversation Fri, 10 Feb 2012 19:46:38 +0000 http://wordpress.org/?v=2.6.2 By: Ed Silverman http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20427 Ed Silverman Tue, 25 Sep 2007 15:49:32 +0000 http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20427 Hi FOIA devotee, You're right - and I'm aware as someone who's made regular FOIA requests to various gov't agencies over the years - that the 20 day requirement refers to acknowleding the request and indicating what will be done. That's not the same thing as filling the request, which I didn't mean to imply. Thanks for writing in and helping to clarify. ed at Pharmalot Hi FOIA devotee,

You’re right - and I’m aware as someone who’s made regular FOIA requests to various gov’t agencies over the years - that the 20 day requirement refers to acknowleding the request and indicating what will be done. That’s not the same thing as filling the request, which I didn’t mean to imply.

Thanks for writing in and helping to clarify.

ed at Pharmalot

]]> By: FOIA devotee http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20425 FOIA devotee Tue, 25 Sep 2007 15:34:52 +0000 http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20425 It is a pervasive misconception that the "the [agency] is supposed to respond to FOIA requests within 20 days" means that the documents being requested are to be provided within 20 days. All that is required, by statute and by court decisions, is that within 20 days of receiving a FOIA request the federal agency must make a determination whether they are going to process the request (which basically means the request has all the information necessary to conduct a search and communicate with the requester, etc.). As the courts and Department of Justice guidance states, "agencies are not necessarily required to release the records within the statutory time limit, but access to releasable records should, at a minimum, be granted promptly thereafter." Now, the FDA may be stonewalling or delaying release of the records - but that is not a violation of the 20-day requirement to let the requester known their FOIA request has been accepted. It is certainly not in keeping with the spirit and intent of the FOIA to play games to delay releasing records in the hopes that a requester will just forget it and move on - but it doesn't mean they've violated a statutory requirement. Next lesson, boys and girls, is just what is a constructive denial. THAT you can take to court - but the "missed the 20 day deadline" is a bogus argument. Go to court over a constructive denial - that gets attention and fed lawyers will bend over backward to avoid going to court. It is a pervasive misconception that the “the [agency] is supposed to respond to FOIA requests within 20 days” means that the documents being requested are to be provided within 20 days. All that is required, by statute and by court decisions, is that within 20 days of receiving a FOIA request the federal agency must make a determination whether they are going to process the request (which basically means the request has all the information necessary to conduct a search and communicate with the requester, etc.). As the courts and Department of Justice guidance states, “agencies are not necessarily required to release the records within the statutory time limit, but access to releasable records should, at a minimum, be granted promptly thereafter.” Now, the FDA may be stonewalling or delaying release of the records - but that is not a violation of the 20-day requirement to let the requester known their FOIA request has been accepted. It is certainly not in keeping with the spirit and intent of the FOIA to play games to delay releasing records in the hopes that a requester will just forget it and move on - but it doesn’t mean they’ve violated a statutory requirement. Next lesson, boys and girls, is just what is a constructive denial. THAT you can take to court - but the “missed the 20 day deadline” is a bogus argument. Go to court over a constructive denial - that gets attention and fed lawyers will bend over backward to avoid going to court.

]]> By: Hank http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20380 Hank Mon, 24 Sep 2007 19:43:24 +0000 http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/#comment-20380 Honig is an interesting guy. Just before the Vioxx withdrawal, when he was already working for Merck, he gave an interview which for a Punjab newspaper that I happened to find via google (what a net!). In it, he noted how often companies spun research findings for medical journal publications compared with the full data set submitted to the FDA. Of couirse, FDA has no control over journal editorial policy, so there was nothing they could have done about it (except maybe shout). Of course, he didn't (I assume) know at the time of the interview that Vioxx was about to hit the fan (harder). If they get Troy's appointment book for 2001-02, and the notes that supposedly were not kept, that will be worth its weight in oval office tapes. Honig is an interesting guy. Just before the Vioxx withdrawal, when he was already working for Merck, he gave an interview which for a Punjab newspaper that I happened to find via google (what a net!). In it, he noted how often companies spun research findings for medical journal publications compared with the full data set submitted to the FDA. Of couirse, FDA has no control over journal editorial policy, so there was nothing they could have done about it (except maybe shout).

Of course, he didn’t (I assume) know at the time of the interview that Vioxx was about to hit the fan (harder).

If they get Troy’s appointment book for 2001-02, and the notes that supposedly were not kept, that will be worth its weight in oval office tapes.

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