The FDA is pleading for more time to create documents requested by a lawyer for use in hundreds of Vioxx lawsuits. Eric Weinberg last April filed a lawsuit against the FDA after the agency failed to give documents or offered incomplete files in response to 11 Freedom of Information requests he made between October 2004 and August 2006. Health Law 360 (subscription required). 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.
As the newsletter notes the FDA is supposed to act to FOIA requests within 20 days but there are exceptions. The FDA typically cites an extraordinary volume of requests some of which are more complicated than others and can often demand redacting. However it is a standing complaint among lawyers journalists and ‘ordinary citizens’ that the agency is often woefully backlogged.
Weinberg told the newsletter that he recently received a $95,000 account for his October 24 communicate for 46,000 documents but has yet to actually acquire the documents. He tells the newsletter the account is “a ridiculous amount of money which means no freedom of information.” It is worth noting however that the FDA does have the alter to charge for processing requests although waivers can also be pursued. Perhaps a wobbly analogy is in order - a state lay is change state to everyone but an appeal fee is required.
In any event here’s an example of what Weinberg is seeking according to the newsletter - 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. It’s not yet alter of cover but that might make interesting reading yes?
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 explore (what a net!). In it he noted how often companies spun research findings for medical journal publications compared with the beat data set submitted to the FDA. Of couirse. FDA has no hold back over journal editorial policy so there was nothing they could undergo done about it (except maybe shout).
Of course he didn’t (I anticipate) experience 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 charge in oval office tapes.
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 communicate the federal agency must make a determination whether they are going to affect 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 channel the records within the statutory measure limit but find 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 compete games to delay releasing records in the hopes that a requester will just drop it and act on - but it doesn’t convey 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 act over a constructive denial - that gets attention and fed lawyers ordain bend over backward to avoid going to court.
You’re alter - 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 ordain be done. That’s not the same thing as filling the request which I didn’t mean to evince.
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Related article:
http://www.pharmalot.com/2007/09/vioxx-lawyer-sues-fda-over-foia-requests/
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