House Committee Will Subpoena FDA Over Ketek
4 CommentsBy Ed Silverman // January 29th, 2008 // 12:19 pm
At its hearing this morning, the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations voted unanimously to approve a motion to subpoena FDA officials and investigators over clinical trial data for the Sanofi-Aventis antibiotic, which has been linked to liver failure.
The committee has been looking into whether Sanofi withheld info about Ketek risks, and whether FDA officials disregarded concerns raised by lower-ranking scientists when Ketek approved in 2004. The committee also wants the FDA to fork over FDA commish Andy von Eschenbach’s briefing book to determine whether he misled the committee during testimony last March. David Ross, a former FDA reviewer who worked on Ketek, last year said Andy’s testimony contained inaccuracies.
Committee staffers are frustrated that the FDA redacted an investigative memo from the FDA Office of Criminal Investigations before showing it to the committee. Congressional aides were told the documents summarize the FDA’s investigation of whether Sanofi-Aventis was aware of problems with a safety study before it was submitted to an FDA panel. Subpoenas will be issued to two FDA investigators, another to a former agency investigator, and one to a private individual who once worked for a contractor overseeing a study of Ketek, according to this memo the committee sent to the FDA.
Although the FDA was chastened for sloppy review, last fall, the agency criticized Sanofi for failing to ensure investigators were in compliance and for failing to follow-up problems with data analysis and documentation; failing to monitor clinical trials; failing to select qualified investigators; and failing to ensure protocols were followed according to its IND. A key example cited was Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., who apparently viewed her Ketek clinical trial as one big piggy bank.
ol cranky
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.
Drug Injury Watch
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…
Chris
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.
Chris
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.