sorry about that...got the same info from other non-AOL members...guess i got it from their news section. i am sure it can be found elsewhere since i heard about it on the radio and then did a search to find the article. I am going to try and copy it here and hope it works
. thanks for the heads up though...
Updated: 06:12 PM EDT
FDA: Will Scrap Premarket Antidepressant Data Plan
By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES, Dow Jones
WASHINGTON -(Dow Jones)- The Food and Drug Administration will likely scrap a plan to require companies to submit longer-term studies on how well proposed psychiatric drugs work in order to be approved following an unanimous vote Tuesday of federal advisors against the proposal.
The FDA convened a panel of outside medical experts to discuss an agency proposal that drug makers submit "longer-term efficacy data" on drugs used to treat depression, bipolar disorder, schizophrenia and a range of other psychiatric illnesses before they are put on the market. Such efficacy data are typically collected after the drugs are put on the market, but it can take up to five years for the information to become available.
The panel voted 12 to 0 on a question about whether long-term efficacy data are needed for drugs that would treat major depressive disorder. The panel did not vote on other psychiatric disorders, but said the FDA should consider each illness separately before implementing a "one- size-fits-all" policy for psychiatric drugs.
"We will very likely take their advice," said Dr. Thomas Laughren, the FDA's director of the division of psychiatry products. He said if the FDA establishes new study requirements and makes recommendations on clinical trial designs that it would likely be for each type of psychiatric illness. An estimated 48 million Americans will be diagnosed with depression, bipolar disorder, schizophrenia, anxiety disorder and other disorders at some point in their lives.
Panel members were unanimous in their view that the current system of allowing drug companies to conduct long-term studies on how well their drugs work in treating psychiatric illnesses after they are put on the market was better than the FDA proposal. A few panel members said it would be ideal if the FDA could mandate that companies provide long-term efficacy data within two years of a drug being placed on the market, which the agency cannot do under current law.
"I still don't really see what the need is to change," said Dr. James McGough, an associate professor at UCLA who specializes in children and adolescent psychiatry.
Dr. Wayne Goodman, the panel's chairman and the chairman of the psychiatry department at the University of Florida in Gainesville, said he was concerned that the public would misinterpret the panel's vote as being against an FDA proposal "to raise the bar" on data required for drug approvals, but said, "I just don't think this is the right approach."
In order to have a drug approved, companies typically submit studies that compare patients on a drug to those on a placebo or fake pill for a six-to-12 week period. The studies are designed to show whether a drug is safe and effective at treating depression and other psychiatric disorders in the acute or short-term phase. Longer-term safety data are also submitted pre-approval, often from patients originally in short-term studies in which patients are then followed for several more weeks or months. The long-term safety studies, however, are not designed to access long-term efficacy.
Dr. Laughren said the issue is that many patients need to be on medication long term and that there's little guidance for clinicians on how to use drugs for the first few years a drug is on the market.
"In fairness, these trials generally are done," he said. "The issue here is whether or not it's acceptable for the clinical community to wait two or three or four years for those results." He noted that European regulators require that both short- and long-term safety and efficacy studies be submitted in order for a drug to be considered for approval.
The pharmaceutical industry argued against requiring long-term efficacy studies before a drug is approved, saying it would delay the already lengthy process of developing new treatments. Representatives from several drug companies including Merck & Co. (MRK), Pfizer Inc. (PFE) and GlaxoSmithKline PLC (GSK) testified against the FDA's proposal.
Dr. David Michelson, the executive director for neuroscience medical research at Eli Lilly & Co. (LLY), explained that getting long-term data would not be as simple as just continuing patients who were in short-term trials for several reasons, including the fact that not enough patients would remain, thereby skewing the results.
He also explained that companies use short-term studies to establish proper doses for long-term treatment. Long-term studies are usually conducted with a new group of patients and they often do not involve putting patients on a placebo pill because of the ethical question of whether people with serious psychiatric disorders should be given fake pills, or no treatment, in a long- term study.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com.
(END) Dow Jones Newswires
10-25-051731ET
Copyright (c) 2005 Dow Jones & Company, Inc.
Copyright (C) 2005 Dow Jones & Company, Inc. All Rights Reserved.
2005-10-25 17:31 -04
. They are also accepting written submissions (Due by Nov. 4 to Mimi Phan at phanm@cder.fda.gov.) See the site for more info. Once again if we all ban together we will make a difference! 
News
Site map
SitemapIndex
RSS Feed