Congressional & FDA Hearings Set For September

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drugawareness

> atracyphd2

> Tue, 3 Aug 2004 00:37:19 EDT

 

> [drugawareness] Congressional & FDA

> Hearings Set For September

>

> The US Congress Oversight and Investigation

> Committee will hold a Hearing on

> " Antidepressants and Children " on Thursday,

> September 9th in Washington, D.C.

> They

> will be investigating what was known by government

> authorities at the FDA and

> the pharmaceutical makers on the safety of

> antidepressants before warnings

> began to be issued earlier this year on safety.

>

> This is the hearing that was suppose to take place

> July 20, 2004 but was

> postponed at the last minute. Two days before the

> hearings we were notified that

> they would not take place on July 20th. The

> following day the Congressman in

> charge of the hearings took a position with a

> Pharmaceutical firm. The story is

> contained in the article to follow this e-mail about

> Tom and Kathy Woodward,

> our directors from PA. It is in today's issue of the

> Philadelphia Inquirer.

>

> Then on September 13 & 14 the FDA will hold their

> second hearing this year on

> the same issue. This Open Public Hearing will be

> held again at the Holiday

> Inn in Bethesda, Maryland.

>

> The Columbia University Report on Children & SSRIs

> will be presented at the

> hearing. See more details in the article below.

>

> For those wishing to speak at the FDA Hearing, that

> portion of the meeting

> will be held on the afternoon of the 13th. To speak

> you should call Anuja Patel

> at 301-827-6790.

>

> For those wishing to submit a written report, call

> 800-741-8138 ex.

> 3014512544 or go to www.fda.gov, slide about half

> way down the page and click on

> References. Then go to Dockets. This on-line report

> may not be ready for a few days

> as the FDA has just announced this procedure today.

>

>

> Ann Blake Tracy, Ph.D.

> Executive Director, International Coalition For Drug

> Awareness

> Author: Prozac: Panacea or Pandora? - Our Serotonin

> Nightmare

> & audio tape on safe withdrawal: " Help! I Can't Get

> Off My Antidepressant! "

>

> Order Number: 800-280-0730

> Website: www.drugawareness.org

>

>

>

> http://news./news?tmpl=story & cid=594 &

>

u=/nm/20040802/hl_nm/health_antidepressants_dc & printer=1

>

> Antidepressant Safety Review Set for September

>

> WASHINGTON (Reuters) - A U.S. advisory committee

> will meet in September to

> once again consider whether antidepressants raise

> the risk of suicide in

> children and teenagers, regulators announced on

> Monday.

>

> The Food and Drug Administration (news - web sites)

> will present a new

> analysis of antidepressant data and ask the panel if

> more research or

> regulatory action is needed, according to a notice

> to be published in the

> Federal Register.

>

> FDA (news - web sites) officials are trying to

> determine if widely used

> antidepressants such as Prozac make children or

> teenagers suicide-prone, or

> whether the disease itself is responsible.

>

> The advisory panel of outside experts considered

> preliminary data in

> February and urged stronger warnings to the public

> while the FDA probed

> further. In March, the agency urged close monitoring

> of antidepressant

> patients for signs of worsening depression or

> suicidal thoughts.

>

> Agency officials, meanwhile, asked Columbia

> University experts to look at

> reports of suicidal behavior among children who took

> antidepressants during

> clinical trials. Many of the reports were vague and

> difficult to interpret,

> FDA officials have said.

>

> The FDA's analysis of the Columbia team's assessment

> " is in the works, " Dr.

> Robert Temple, FDA's associate director for medical

> policy, said in an

> interview.

>

> He said he did not know whether the FDA would

> release its analysis ahead of

> the Sept. 13-14 advisory committee meeting.

>

> " We'll try to let people see what we have as soon as

> we can, " Temple said.

>

> Some lawmakers and other critics have questioned

> whether the FDA tried to

> keep secret one agency reviewer's conclusion that

> the drugs were linked to a

> higher suicide risk. FDA officials have denied the

> charge.

>

> Some also have asked why the FDA has taken longer to

> act than British

> authorities, who have advised doctors not to

> prescribe most of the drugs

> known as selective serotonin reuptake inhibitors to

> anyone under 18.

>

> [Non-text portions of this message have been

> removed]