posting a response from the FDA - legal issues?
 

I wrote a letter to the FDA and I would like to post their response on my blog. Their response does not say confidential or anything on it. Does anyone know whether there are any legal issues with publicly posting a response one has received from a federal entity?

Lordy, has it come to this?
 

I am no more qualified to give legal advice than I am medical, but I will tell you what I would do. Unless it is stamped "Classified" I'd post it and dare them to say anything. If it is stamped thus, I'd probably do it too on general principles.

:D For some reason that made me giggle Rick and then I thought, "If it's not for the public they need to tighten it up some..maybe w/out names?

I'd post it..
paula

information in public domain
 

am unaware if my situation is the same--but i recently asked for (under the freedom of information act) and received reports of all adverse events of a drug (actually, they only sent the reports from 1997 onward--to obtain the others will cost $204.00 and the information from these earlier dates are reports for adverse events for ALL drugs from 1987 onward--not segregated as to drug--just 1.8 million adverse effects reports that one could wade thru for a few years--or at my rate, decades)
I received 2 CDs and asked a lawyer if it was okay to share the info with several individuals who are conducting the same research and he said this information is in the public domain--that i am welcome to copy it and send it to anyone I wish because they could go to the archives and find the info themselves. i of course will not charge them for sharing this info.
hope this helps-
though after reading my response, do not feel it is truly applicable. so will give you my opinion--I would post it . madelyn

public domain
 

I would say if they send to you, its public unless otherwise noted.

Too much already is proprietary even if it is in the public interest to release the information. For example, Amgen's meeting in January 2005 where, the toxicology data from the primate study (the major reason for halting development) were examined and the FDA said it would be safe for the company to continue the patients on the treatment, who have already undergone the major risk of brain surgery. We have learned exactly what transpired, but the FDA has not made this opinion known publicly, and to date Amgen has not published that data. Through their PR office, they say they are going to publish the data and they want to meet with patient advocates to discuss the toxicology data and their plans to move ahead to develop GDNF, but this hasnt happened yet.

Perry

You can always email me or us as the case may be

I work for a federal agency, and to the best of my knowledge anything they write to you is free for you to post wherever and however you choose, as long as you post what was actually sent... the taxpayers paid for it, so it's in the public domain.

A Lesson in International Law
 

As a "retired" lawyer (or is it just "realtired"?), who a querter century ago once worked for the IRS, I go by this general rule of thumb in the following three countries: In the USA, that which is not expressly prohibited is permitted; in the former Soviet Union, that which is not expressly permtted is prohibited; in Italy, everything is permitted. especially that which is expressly prohibited.

I love that joke. Seriously though, I believe a private response to a private inquiry to the FDA may be publically published unless it says something to the contrary in the letter itself. Documents released under the FOIA are by definition publishable because the issuing agency has determined that the public has a right, in our free society, to know. Unlike Great Britain, we are still free from an Official Secrets Act, all appearances to the contrary lately notwithstanding.

I gotta include my favorite international joke. What's the differrence between dinner parties in Heaven and dinner parties in Hell? In Heaven, the British answer the door, the French cook the meal, the Italian provide the entertainment, and the Germans do the organizing; in Hell, the French answer the door, the British cook the meal, the Italians do the organizing, and the Germans provide the entertainment.

Hope this helps, with something,

Greg

Those "Russian" rules seem to apply in New York City, too! My wife and I once parked our car in an unmarked lot and had the car towed. When they brought the car back (after I gave them $250) I asked the guy why there wasn't a "No Parking" sign. "Did you see a sign that said you COULD park there?" he asked. He was serious. I just stared at him in disbelief.

oh - and come on by
 

to my blog, will try to post both the letter and my response tonight

anukets-crusade