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Public Citizen Sues FDA


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http://www.citizen.org/litigation/forms/cases/getlinkforcase.cfm?cID=993

 

Public Citizen v. Food and Drug Administration and Department of Health and Human Services Topic(s): Government Transparency – FOIA
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Advisory committees furnish expert advice to federal government agencies. The FDA has approximately 50 advisory committees and panels that the agency advice on issues related to FDA-regulated products, such as whether the FDA should approve new medical products, request additional studies, or change a product’s labeling. The FDA posts on its website a roster of the members serving on each advisory committee, frequently accompanied by members’ curricula vitae (CV). The FDA frequently redacts the CVs, however, by blacking out information about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles. Many of the redactions were unaccompanied by any indication of why, but many were marked to indicate that the FDA believed that the redacted information fell under the Freedom of Information Act (FOIA) exemptions for confidential commercial information and for material the disclosure of which would cause an unwarranted invasion of privacy.

CVs are compiled by individuals specifically for the purpose of sharing information about the individuals’ background. Believing that the redactions based on the FDA’s determination that the information is “confidential” or “private” are thus unjustified under FOIA, and that the information redacted would help the public better to assess the backgrounds, qualifications, and potential biases of advisory committee members, Public Citizen submitted a FOIA request to the FDA in May 2014, in which Public Citizen requested “unredacted” copies of the CVs. As of April 2016, only three of the FDA’s six divisions had responded to the request, and all but one continued to redact information from the CVs.

Public Citizen sued the FDA under FOIA seeking an order compelling the FDA to respond fully to its request, without the redactions that appear to be wholly unjustified. In addition, because FOIA requires agencies to post frequently requested records online and the FDA’s website concedes that advisory committee member CVs are frequently requested, the suit seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward.

 

WARNING THIS WILL BE LONG
Had a car accident in 85
Codeine was the pain med when I was release from hosp continuous use till 89
Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year
Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above.
One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking.

As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. 

http://survivingantidepressants.org/index.php?/topic/1096-introducing-myself-btdt/

There is a crack in everything ..That's how the light gets in :)

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from this new to me pharma blog

http://www.scoop.it/t/pharmaguyevents

WARNING THIS WILL BE LONG
Had a car accident in 85
Codeine was the pain med when I was release from hosp continuous use till 89
Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year
Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above.
One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking.

As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. 

http://survivingantidepressants.org/index.php?/topic/1096-introducing-myself-btdt/

There is a crack in everything ..That's how the light gets in :)

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