Comments on: FDA Warns Amgen Over DTC Brochure http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/ News, Comment and Conversation Fri, 10 Feb 2012 19:14:11 +0000 http://wordpress.org/?v=2.6.2 By: Maroha http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/#comment-379887 Maroha Sat, 01 Nov 2008 00:45:59 +0000 http://www.pharmalot.com/?p=17086#comment-379887 Compliance A. I was a wee bit suspicious at the 50K letters too. So I did a search of FDA DDMAC warning letters in the last three years at http://www.accessdata.fda.gov/scripts/wlcfm/export_report_excel.cfm But I found different results: 2008 first 3 quarters (33 letters), 2007 (2), 2006 (0). Here were the 2007 letters: Morton Grove Pharmaceuticals, Inc. Dec 13, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded Wyeth Pharmaceuticals Inc. Dec 10, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded Seems strange that these numbers are all over the place. What's driving them? Some extra time on DDMAC's hands? Also, are you counting warnings from divisions other than DDMAC? Compliance A.
I was a wee bit suspicious at the 50K letters too. So I did a search of FDA DDMAC warning letters in the last three years at http://www.accessdata.fda.gov/scripts/wlcfm/export_report_excel.cfm

But I found different results: 2008 first 3 quarters (33 letters), 2007 (2), 2006 (0).

Here were the 2007 letters:
Morton Grove Pharmaceuticals, Inc. Dec 13, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded

Wyeth Pharmaceuticals Inc. Dec 10, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded

Seems strange that these numbers are all over the place. What’s driving them? Some extra time on DDMAC’s hands?

Also, are you counting warnings from divisions other than DDMAC?

]]> By: MidwestRebel http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/#comment-379711 MidwestRebel Thu, 30 Oct 2008 19:40:15 +0000 http://www.pharmalot.com/?p=17086#comment-379711 Amen, amen, Pharmalot. Pharma KNOWS the rules and thumbs their collectives noses at them, repeatedly. If they DON'T know the rules, they should lose their license to operate. Also, if the FDA can't/won't be vigilant and excercise their authority to the full extent of the law, defund their budget of taxpayer dollars. Let's face it...with few exceptions, the FDA's budget seems to be spent protecting the industry, NOT consumers. As with kids, if there are no consequences for disobedience, you may as well save your breath. Amen, amen, Pharmalot. Pharma KNOWS the rules and thumbs their collectives noses at them, repeatedly. If they DON’T know the rules, they should lose their license to operate.

Also, if the FDA can’t/won’t be vigilant and excercise their authority to the full extent of the law, defund their budget of taxpayer dollars. Let’s face it…with few exceptions, the FDA’s budget seems to be spent protecting the industry, NOT consumers.

As with kids, if there are no consequences for disobedience, you may as well save your breath.

]]> By: Compliance Analyst http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/#comment-379689 Compliance Analyst Thu, 30 Oct 2008 16:32:19 +0000 http://www.pharmalot.com/?p=17086#comment-379689 Doing a quick search for the last two years of warning letters, it appears that it would be closer to 50 rather than 50,000. Here is a summary of DDMAC warning letters for the past say 10 years: YEAR # OF DDMAC WARNING LETTERS 2008 13 (first 3 quarters only) 2007 20 2006 22 2005 29 2004 23 2003 25 2002 28 2001 64 2000 75 1999 108 1998 156 1997 139 Based on that there haven't been 50,000 (let alone 1000) in the past 10 years. I always prefer to work with facts.... Doing a quick search for the last two years of warning letters, it appears that it would be closer to 50 rather than 50,000. Here is a summary of DDMAC warning letters for the past say 10 years:
YEAR # OF DDMAC WARNING LETTERS

2008 13 (first 3 quarters only)
2007 20
2006 22
2005 29
2004 23
2003 25
2002 28
2001 64
2000 75
1999 108
1998 156
1997 139

Based on that there haven’t been 50,000 (let alone 1000) in the past 10 years. I always prefer to work with facts….

]]> By: ssmith http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/#comment-379684 ssmith Thu, 30 Oct 2008 14:54:44 +0000 http://www.pharmalot.com/?p=17086#comment-379684 Dictionary definition DTC: testing limits of credible marketing - because you can never have enough Viagra / Cialis ads.... Dictionary definition
DTC: testing limits of credible marketing - because you can never have enough Viagra / Cialis ads….

]]> By: Dan A. http://www.pharmalot.com/2008/10/fda-warns-amgen-over-dtc-brochure/#comment-379679 Dan A. Thu, 30 Oct 2008 12:21:37 +0000 http://www.pharmalot.com/?p=17086#comment-379679 I understand that the FDA issues nearly 50 thousand warning letters to drug companies for such activities every year, which clearly is not a deterrent, and likely an attempt to pacify the public with the perception of fictional regulationn by the FDA. I understand that the FDA issues nearly 50 thousand warning letters to drug companies for such activities every year, which clearly is not a deterrent, and likely an attempt to pacify the public with the perception of fictional regulationn by the FDA.

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