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-----Original Message-----<br>
From: vince <vince_19805@yahoo.com><br>
To: undisclosed-recipients:;<br>
Sent: Mon, 4 Aug 2008 2:25 pm<br>
Subject: Pharmalot - FDA Issues New Rules For Advisory Committees<br>
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<div align=justify><BIG><B><BIG><BIG><BIG><SMALL><SMALL><SMALL>**** note: This is a private list. I send out alerts, useful news items, and comment to a group of mental health professionals, decision makers and activists. <FONT color=#009900>(OK to repost and to include this header and comments)</FONT>. If you do not want to receive any of these emails, please let me know. To preserve privacy, I blind copy the entire list. Vince Boehm ****</SMALL></SMALL></SMALL></BIG></BIG></BIG> <br>
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<div align=right><A href="http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comments" target=_blank><B><BIG><BIG>Leave a Comment</BIG></BIG></B></A><br>
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<H1><A title="Permanent Link to FDA Issues New Rules For Advisory Committees" href="http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/" target=_blank rel=bookmark>FDA Issues New Rules For Advisory Committees</A></H1><SMALL><B><BIG><BIG>By Ed Silverman <br>
<A href="http://www.pharmalot.com/2008/08/04/" target=_blank>August 4th, 2008</A> <br>
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<BLOCKQUOTE><BIG><B><BIG><BIG><FONT face="Times New Roman, Times, serif">The changes involve conflicts of interest and waivers for panel members; advisory committee voting procedures; the timing of committee briefing materials to be released and the procedures for deciding when an advisory committee meeting should be held. The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. <A href="http://www.fda.gov/oc/advisory/factsheet080408.html" target=_blank>Here is a summary</A>, and you can <A href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html" target=_blank>look here</A> to read the individual guidances.</FONT></BIG></BIG></B></BIG>
<div><B><BIG><BIG><FONT face="Times New Roman, Times, serif">The most contentious issue has to do with concern over conflicts involving committee members, a hot-button topic that regularly embroils the FDA (<A href="http://www.pharmalot.com/2008/08/provenge-activists-pressing-their-fight-again/" target=_blank>see this item earlier today</A>). The FDA has long argued finding experts without financial conflicts is arduous, if not impossible, because many top-flight physicians and academics serve as industry consultants.</FONT></BIG></BIG></B></div>
<div><B><BIG><BIG><FONT face="Times New Roman, Times, serif">To answer the criticism, the FDA has these new rules: For starters, if an individual, his or her spouse, or minor child has potentially conflicting financial interests totaling more than $50,000, he or she would not be allowed to participate in that meeting.</FONT></BIG></BIG></B></div>
<div><B><BIG><BIG><FONT face="Times=2 0New Roman, Times, serif">Second, the guidance specifies four scenarios where a conflict is significant and FDA does not intend to issue a waiver, even if the potential personal conflict is below $50,000. (For example, if the advisor is the principal investigator of a clinical trial of a product about which the committee will be providing advice, the advisor will not be allowed to participate in that meeting.) Third, before a waiver is issued, the FDA will require a showing that the waiver is necessary to ensure the committee has “essential expertise.” Fourth, as now required by law, the FDA will limit the number of waivers granted. </FONT></BIG></BIG></B></div>
<div><B><BIG><BIG><FONT face="Times New Roman, Times, serif">[<STRONG>Our thought</STRONG>: $50,000 is still a lot of money. Disagree? Ask someone who thinks $4 for a gallon of gas is too much. We recognize there is no perfect situation, but the threshhold remains stubbornly high.]</FONT></BIG></BIG></B></div>
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<div align=justify><B><BIG><FONT color=#cc0000><BIG><SMALL><SMALL>FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law
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<div align=justify><FONT color=#cc0000><B><BIG><BIG><BIG><BIG><SMALL><SMALL><SMALL><SMALL>The information herein shall not be considered an endorsement of anyone discontinuing psychiatric drugs. If you are stopping taking medication </SMALL></SMALL></SMALL></SMALL></BIG></BIG></BIG><BIG><BIG><BIG><BIG><SMALL><SMALL><SMALL><SMALL>IT IS ADVISABLE TO REDUCE DOSES GRADUALLY WITH EXTREME CAUTION, </SMALL></SMALL></SMALL></SMALL></BIG></BIG></BIG></BIG><BIG><BIG><BIG><SMALL><SMALL><SMALL><SMALL>as it is difficult to predict who will have problems withdrawing. It is worth getting as much information and support as you can, and involving your doctor wherever possible. You will find withdrawal information here: <A class=moz-txt-link-freetext href="http://www.mind.org.uk/Information/Booklets/Making+sense/Making+sense+of+coming+off+psychiatric+drugs.htm" target=_blank>http://www.mind.org.uk/Information/Booklets/Making+sense/Making+sense+of+coming+off+psychiatric+drugs.htm</A></SMALL></SMALL></SMALL></SMALL></BIG></BIG></BIG><br>
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<B><BIG><BIG><BIG><BIG><FONT color=#993300><SMALL><SMALL><SMALL><SMALL>FOR MORE INFORMATION ON WITHDRAWAL:: Get <FONT color=#009900>Peter Lehmann's</FONT> book, </SMALL></SMALL></SMALL></SMALL></FONT></BIG></BIG></BIG><SMALL><A href="http://www.peter-lehmann-publishing.com/withdraw.htm" target=_blank>Coming off Psychiatric Dru
gs: Successful Withdrawal from Neuroleptics, Antidepressants, Lithium, Carbamazepine and Tranquilizers</A>. <FONT color=#993300>This valuable resource comes in US, UK, Greek. and German editions.<br>
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