Comments on: House Committee Will Subpoena FDA Over Ketek http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/ News, Comment and Conversation Sun, 21 Mar 2010 07:14:52 +0000 http://wordpress.org/?v=2.6.2 By: Chris http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-121254 Chris Wed, 30 Jan 2008 03:49:54 +0000 http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-121254 Woops. My Bad. I read it too fast and too late. I thought it was the FDA waking up. I was wrong. It's just another moment when Congress is trying to shake the FDA into waking up. So basically it's a false alarm. I apologize. Don't anyone in phrma panic. FDA is still asleep at the switch. I saw FDA and Ketek and got all excited that maybe the lights went on and I got all ahead of myself. Alas, all is well, some member of Congress will bluster about something, there will be some media stories and lots of blogging and when the media goes away so will congress and the FDA can turn over and get back to it's nice long hibernation. My apologies, if I alarmed anyone. Woops. My Bad. I read it too fast and too late. I thought it was the FDA waking up. I was wrong. It’s just another moment when Congress is trying to shake the FDA into waking up. So basically it’s a false alarm. I apologize. Don’t anyone in phrma panic. FDA is still asleep at the switch. I saw FDA and Ketek and got all excited that maybe the lights went on and I got all ahead of myself. Alas, all is well, some member of Congress will bluster about something, there will be some media stories and lots of blogging and when the media goes away so will congress and the FDA can turn over and get back to it’s nice long hibernation.

My apologies, if I alarmed anyone.

]]> By: Chris http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-121246 Chris Wed, 30 Jan 2008 03:44:21 +0000 http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-121246 Wow. FDA re-enters the picture. Every once and a while the FDA wakes up and it always startles me. They are always a little late and a little weak but they like to remind us that there is still a regulator in the largest unregulated regulated industry. I am getting more and more used to class actions on product liability issues, class actions on shareholder derivative suits, congressional inquiries, U.S. attorneys and the OIG, states and more states, but the rare appearance of the FDA still catches me off-guard. It would be funny if it wasn't so sad. Wow. FDA re-enters the picture. Every once and a while the FDA wakes up and it always startles me. They are always a little late and a little weak but they like to remind us that there is still a regulator in the largest unregulated regulated industry. I am getting more and more used to class actions on product liability issues, class actions on shareholder derivative suits, congressional inquiries, U.S. attorneys and the OIG, states and more states, but the rare appearance of the FDA still catches me off-guard.

It would be funny if it wasn’t so sad.

]]> By: Drug Injury Watch http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-120953 Drug Injury Watch Tue, 29 Jan 2008 23:14:04 +0000 http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-120953 <strong>Subpoenas Issued For Witnesses To Appear At February 2008 U.S. House Committee Hearing On Ketek ...</strong> Congress Wants To Learn When Sanofi-Aventis And The FDA Learned About Fraud Involved With Ketek Study 3014 (Posted by Tom Lamb at DrugInjuryWatch.com) Soon after noon on January 29, 2008 Ed Silverman posted on his Pharmalot blog, House Committee Will... Subpoenas Issued For Witnesses To Appear At February 2008 U.S. House Committee Hearing On Ketek …

Congress Wants To Learn When Sanofi-Aventis And The FDA Learned About Fraud Involved With Ketek Study 3014 (Posted by Tom Lamb at DrugInjuryWatch.com) Soon after noon on January 29, 2008 Ed Silverman posted on his Pharmalot blog, House Committee Will…

]]> By: ol cranky http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-120602 ol cranky Tue, 29 Jan 2008 19:10:55 +0000 http://www.pharmalot.com/2008/01/house-committee-will-subpoena-fda-over-ketek/#comment-120602 Weren't the Ketek trials the ones that Sanofi-Aventis got their knuckles wrapped for due to lack of oversight of their CRO? Once again, I say hold the execs and other staff directly involved in the management of these studies accountable. They are not the only company with mid-level (clinical trial management) staff that abrogates their responsibility to actually manage a trial because they think a transfer of obligations is a transfer of responsibilities. Once individuals are held accountable and unable to work in clinical development, others who have that same laissez-fair attitude will HAVE to take notice. Weren’t the Ketek trials the ones that Sanofi-Aventis got their knuckles wrapped for due to lack of oversight of their CRO? Once again, I say hold the execs and other staff directly involved in the management of these studies accountable. They are not the only company with mid-level (clinical trial management) staff that abrogates their responsibility to actually manage a trial because they think a transfer of obligations is a transfer of responsibilities. Once individuals are held accountable and unable to work in clinical development, others who have that same laissez-fair attitude will HAVE to take notice.

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