Congressman To FDA Commish: ‘Resign’
6 CommentsBy Ed Silverman // February 15th, 2008 // 7:38 am
Bart Stupak, who chairs the House subcommittee on Oversight & Investigations (pictured left), has had it with Andy von Eschenbach. In the wake of probes into the Ketek antibiotic and a failure to inspect facilities connected to the side effects and deaths linked to the Heparin blood thinner, the Democrat from Michigan wants Andy’s head.
And so he believes the silver-tongued FDA leader (pictured right) ought to step down because “it’s just a total lack of leadership,” he tells the Associated Press. Stupak, who has railed against the FDA over safety issues involving various drugs over the years, goes on to say that he’s lost confidence in Andy and other top FDA officials over the handling of inspections and oversight, in general.
An FDA spokeswoman tells the AP “there isn’t really anything to say beyond we’ve been responsive to the congressman as much as possible.”
Stupak’s panel has investigated the Sanofi-Aventis Ketek antibiotic, which was linked to death and liver failure in 2006. Stupak alleges the FDA approved the antibiotic despite knowing a key safety study of the drug was plagued by faulty data.
Earlier this week, Stupak and John Dingell, another Michigan Democrat, who chairs the House Energy & Commerce Committee, threatened to hold Health and Human Services Secretary Michael Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee in the probe. Leavitt oversees the FDA and other health care agencies.
The documents in question were used to prepare von Eschenbach for his appearance before House lawmakers last year. The commissioner testified that FDA did not use the flawed safety study to approve Ketek. But Stupak has called that statement untrue and subpoenaed von Eschenbach’s notes to determine if he lied under oath. The agency has said there was no intention to deceive the public.
Sanofi-Aventis SA has said one of its predecessors, Aventis, was not aware of fraud connected with a key Ketek study until after the study was submitted to the FDA.
Additionally, Stupak said he was upset that US health officials hadn’t inspected a Chinese factory that may be the source of problems with a Baxter International blood thinner tied to hundreds of reports of allergic reactions and the four deaths.
Stupak said in a conference call with Michigan reporters that his subcommittee asked for briefings Heparin “and they’ve told us they’re too busy. They can’t brief us on what’s going on. Maybe it’s time that we replace the leadership there at the FDA.”
The FDA wants to inspect the facility as soon as possible and has requested its inspection data and other reports.
Baxter has said it buys the active ingredient for heparin from a supplier that manufactures it at the Chinese factory and at a U.S. facility. The company said it inspected both facilities last year and found no quality issues but it plans to re-inspect the facility as part of its own investigation.
Source: Associated Press
Matthew Arnold
Okay, but “Silver-tongued?” Andy’s always struck me as a masterful bloviator of bureaucratese, one of those Washington creatures practiced in the art of speaking at length and saying nothing. I might have gone with “Leaden-tongued.” And hey, not to disparage the guy. It’s a skill of sorts in that town. They can’t all be Barack Obama, and a Sorkinesque “hopemonger” probably wouldn’t fare well in the glare of one of Waxman’s hearings.
Ed Silverman
Hi MA,
So you think I was too nice, eh? Perhaps my sarcasm was too obscure. You’re correct. I’ve seen him speak. I’ve listened to him speak many times. He’s smooth, very smooth. But in a way that makes his words sometimes hard to understand. Impenetrable comes to mind. That’s a special talent, though. Not everyone can spend a great deal of time saying nothing and still sound eloquent. You’d think he’s running for election somewhere.
Cheers
ed
Chris
The FDA is asleep at the switch, period. Congress needs to do a lot more than demand a leadership change. Who cares about that? Another clone will be appointed. This FDA has failed to enforce the laws and regulations entrusted to it, and American patients are paying the price over and over again. The omissions in oversight are so substantial that Congress can no longer pass blame to FDA leaders. Congress holds the ultimate power, the power of money. Congress needs to find ways to withhold funding if substantial changes are not made. While I am certainly no fan of no-child-left-behind (not by a long stretch), if we can find a way to hold the county’s teachers accountable then Congress can find a way to hold FDA accountable. Calling for resignations is just political jockeying. How about calling for overhaul with milestones and financial conditions. Now that would be leadership and oversight.
I work in industry and have for 20 years and in my personal view FDA is our FEMA. It’s a fundamentally failed agency. Of course we all know that a big part of the problem is that it is terribly underfunded and so rather than address that the politicians simply do what they do best — grandstand for the media — and that’s what we are seeing here. But make no mistake the political and financial situation found at the FDA today leaves it fundamentally unable to fulfill its mission. And I see the terrible downside from an industry perspective in that there is virtually no respect and no risk or concern about enforcement. The pharmaceutical industry today is a quasi-regulated industry. It is regulated in the sense that industry players cannot market products without specific approval. But the regulation pretty much stops there. We should not be surprised when we see the Merck/Schering Vytorin or sanofi KETEK scandals. You get what you pay for.
Andy von Eschenbach should not step down he should be forced out as part of a major overhaul. 2008 funding should have been contingent on improvements that could be measured. The U.S. pharmaceutical industry used to be a hallmark of american innovation. But today we find it unproductive and lacking any sense of integrity or respect. FDA and industry leaders share accounability for that. And if you have worked in it and watched all this happen over the last decade or so, you are left simply disgusted.
JM
Perhaps the FDA Commissioner appointment should look more like the Fed Chairman (maybe not that long…) or other executive appointments that do not coincide with political cycles…
LILI
ALL THIS WRITING IS NOT CHANGING THE PROBLEMS THAT PHARAMCEUTICALS ARE CREATING. AMERICANS NEED ACTION! NOT SPEECHES AND CONVERSATION! UNFORTUNATELY, BECAUSE OF MY AND MY FAMILIES EXPERIENCES WITH DOCTORS AND MEDICATION WE HAVE HAD TO COPE WITH EXTREME TRADGERIES THAT FEDERAL AND STATE REPRESENTATIVE HAVE ALLOWED TO EXIST. AMERICANS MUST SPEAK UP AND AND TAKE CONTROL.
Bless the Truth
Lili,
My heart bleeds as I read your comments especially knowing what I know about drug safety and pharma greediness.
FDA to me, is either an obsolete organization, corrupt or completely not competent to protect the American people. I am shocked how little or no oversight FDA has over clinical trials, ethics and data integrity. FDA is reactive but not proactive. They approve drugs that should not approved with so call “black label” only to pull them out of the market after innocent people have been killed. It is shameful, that we are in the mess, but FDA is not of any help.