The FDA is pleading for more time to produce 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 provide documents or offered incomplete files in response to 11 Freedom of Information requests he made between October 2004 and August 2006, Health Law 360
reports (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 respond 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 require 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 bill for his October 24 request for 46,000 documents, but has yet to actually receive the documents. He tells the newsletter the bill is "a ridiculous amount of money, which means no freedom of information." It is worth noting, however, that the FDA does have the right to charge for processing requests, although waivers can also be pursued. Perhaps a wobbly analogy is in order - a state park is open to everyone, but an entrance 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 clear, of course, but that might make interesting reading, yes?
3 Comments
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.
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.
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