By Ed Silverman // July 11th, 2008 // 11:55 am
We have written before about the large bonuses given some FDA officials - see here and here - but there is nothing like watching FDA commish Andy von Eschenbach avoid the issue. And you can watch him prevaricate now that CBS Evening News caught up to the story…
Laurie
This just continues to highlight the dismal failure of the FDA. Retention bonuses are to retain the best and the brightest, obviously Andy doesn’t understand this concept, which comes as no surprise.
hymie
Governments promote corruption just like in the military but then cut back on medicare and welfare. ENRONomics, trickle down supply side free market payoffs to loyal hatchet men. If you cant pay you cant play-so if you can find a job you can work if you can pay $5.00 a gallon to fuel your loyality to their economy.After you pay off the loan sharks for your house and SUV you can buy chinese processed food and drink gallons of cornsyrup like a good citizen should.
Dingle
Do we want our government agencies to be high performing organizations or unproductive bureaucracies? Granted, we still may be getting the ladder, but incentives are critical to develop and retain talent. And is $37k really that egregious?
James
Dingle, I want our gov’t agencies to be as low-performing as possible, as, no matter how talented they are, I trust my judgment to make decisions about my life and health more than I trust any of them. In return, I want to pay as little in taxes as is needed.
But clearly, especially based upon the comments here, I am in the minority.
Jake
As a pharma executive, my somewhat educated guess is that FDA officials are still underpaid when compared to private-sector counterparts. When you add the fact that working at the FDA carries with it the risk of being on 60 Minutes or lectured by a Congressional panel if something goes wrong, we are making it a very easy decision for talented executives to choose the private sector over the FDA.
Jaynesday
Ultimately this is another nail in the Pharma image coffin. The lead off of the story begins with a rundown of food/drug issues. In a sentence - Why should we give such large FDA bonuses when there have been these serious food and drug product issues unleashed on the American consumer?
What is the root cause of the drug related problems? Is it the FDA - No, not really, though when a pharma company tries to hit a home run with a blockbuster drug that falls short the FDA has been known to drop the ball and let the runner continue around the bases. (See you in Chicago tomorrow - Go Cubs!)
The root cause is the poor performance of the drug companies. Allowing poor quality products to be consumed is what ultimately the American public is bound to realize.
Every exposure to bad national press elevates the public’s attention level a little more.
In summary - The FDA has been good for some pharma companies that prefer to allow bad product to stay on the market. The Supreme Court is trying to help also but ultimately the lowsy product performance speaks loudly to the consumer. There won’t be enough “hushing” of problems eventually. The cacophony of multiple problems *will* reach the collective ears of the consumer. They will respond in kind.
Laurie
“As a pharma executive, my somewhat educated guess is that FDA officials are still underpaid when compared to private-sector counterparts.”
Then the FDA officials are in the wrong job. As with almost EVERY government job, the salary is less than the private sector. One knows this going in. But, in most cases, their motivation is something other than salary.
If these bonuses went to those who actually did the research, investigation etc, I would have no problem with it.
But these bonuses went to those who’s actions have been criticized widely and their motivations questioned.
In the private sector, that gets you fired, not a bonus.
Jaynesday
Laurie,
I’ve really got to second what you said.
“In the private sector, that gets you fired, not a bonus.”
Here’s how the situation might be played out in the private sector -
Things are not going well.
Your staff reports to the public that your company is failing to uphold its duty to your customers. They even say that their managers are forcing them to falsify critical reports. http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html
Then an in depth investigation goes to the board of directors that states that the company is failing in almost every one of its objectives.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
Many of your customers are in an uproar about how your service has failed to perform.
For most companies this would certainly be the end of the line for its management and maybe even its future existence.
MASSIVE BONUSES ALL AROUND???
Lorine
Congress has allowed the FDA to get away with thumbing their nose at the boss for so long, it is beyond tragic. If this was any other employer/employee relationship, the employee would have been shown the door a long time ago. Instead, congress give the FDA more money to do a job they are incapable of doing and uses the money to give themselves BIG FAT bonuses on the taxpayers’ dime.
Somebody needs to do something about this!! Are you listening, McCain, Obama, the tooth fairy, santa clause, somebody, anybody???
tommy twotoes
Add to it money(tax free) paid by hedge funds and Big Chemo Pharma’s for inside info and to keep small biotechs like Dendreon’s Provenge off the market. Some of these guys I bet are pulling in $1,000,000 plus! JMHO!
Justice in MI
As we’ve discussed before, the FDA’s overall budget is tiny compared with other regulatory agencies and similar - EPA, NASA, Homeland Security, etc. And it’s essentially stayed the same for the past twenty years.
So the image of money being poured into FDA ain’t the way it is. We have a lot of great people working there, and a senior management many of whom engage in varying degrees of CYA’ing, corruption, and similar.
As with a company or industry, it is critical to differentiate separate levels and departments within FDA. The problem is - and has been - almost entirely in the managerial ranks, and at the top.
Moonshooter
The people at the FDA are paid salaries to perform their duties in an “efficacious” way. Bonuses are for those who have performed their duties above and beyond what is expected of them.
Many of them have failed to perform their duties. They should get a reduction in their pay packages and pass the bonuses to the citizens of the country who have been harmed by their dereliction of duty.
Lawrence
While we worry about the so-called Al-Qaeda that our Government is protecting all US citizens from. We failed to realize they have set up two of the Biggest Terrorist Cells right here in the Good Ole US of A! Those Cells are more commonly known as the FDA & SEC! Will it take a Civil War for the People to take their Country back?
Justice in MI
FDA is a very easy target. As above, one has to focus on particular layers and departments. Otherwise, we love to hate it because it is more visible (and easier to imagine “whipping”) than Congress or the Administration or industry or other relevant players. Were that it was so simple.
It’s an old game.
MikeK
Hey Dingle, spare me on your worries about incentives being “critical to develop and retain talent”. You aren’t John Dingell are you? The one who should be investigating the shenanigans at the FDA in the Provenge case?
Regardless, if you think we need to develop and retain people like Richard Pazdur, you are way off base! He is poison for the American people! His track record shows his business relationships are more important than the health of the taxpayers.
Further, he left a six-figure job to work at the FDA. His choice, not ours. You can read that story here:
http://money.cnn.com/magazines/fortune/fortune_archive/2006/02/20/8369155/index.htm
So why do you suppose he left that six-figure job? It wouldn’t have been because he hobnobs with big pharmaceutical lobbyists? Bristol-Myers Squibb wouldn’t have any influence on his decisions would it? Are there financial rewards there that would make it better than a six-figure job? I don’t know, I am just asking? I’ll try not to be too naive, if you promise the same.
Just study the ImClone case. He knew he couldn’t release FDA info but according to some good sources he was able to hand them off a Bristol-Myers Squibb lobbyist so people could find out inside FDA information to the detriment of patients and investors who pay his salary. He was dragged before Congress on this one.
And isn’t that what he did in the Provenge case? Handed off letters that FDA employees signed off on so they could be leaked by The Cancer Letter? No, I ain’t paying for this. They do not deserve bonuses.
Who needs to retain people who flip-flop like this idiot:
The FDA extended Avastin’s use to breast cancer and Pazdur said:
“We wanted to have the regulatory flexibility to approve effective drugs where there isn’t overall survival,” said Dr. Richard Pazdur, who oversees cancer drugs at the F.D.A. He said the agency had sympathy for the view that delaying the progression of life-threatening disease “may be a direct clinical benefit in itself.”
Dr. Pazdur of the F.D.A. and Dr. David Schenkein, a senior vice president of Genentech, both said it was undecided whether a survival benefit would be needed to obtain full approval.
http://www.nytimes.com/2008/02/23/business/23drug.html?_r=2&th&emc=th&oref=slogin&oref=slogin
When it came to Provenge, Pazdur told Businessweek this:
The agency, he says, is routinely made a scapegoat by both patients and company executives who refuse to abandon a drug despite an obvious lack of efficacy. “Believe me, if there were a clear survival effect, the drug would be approved,” says Pazdur.
http://www.businessweek.com/magazine/content/08_22/b4086000467675_page_2.htm
When pushed about Provenge, the FDA says the decision was based on science, a nice vague answer. But for Avastin, Pazdur said the decision was because the agency had sympathy. Why not sympathy for 96,000 American men who have late stage prostate cancer and have no other option?
Avastin didn’t have to show survival but Provenge must? Where is the consistency here? But the reality is, Provenge did show survival and that was the number one reason why they called for an FDA Advisory Committee!!
The Advisory Committee voted Provenge safe 17-0 and that it showed substantial evidence of efficacy, 13-4. That Advisory Committee was called and we paid for it with our tax dollars because Provenge showed survival! Pazdur is a liar and I refuse to pay bonuses to retain evil talent like his and I will stay after this until the FDA throws him out the door!!
But let’s look at the FDA as a whole:
Didn’t Von E cry that they didn’t have enough money to keep up with the science and the inspections? And Congress believed him and sent them $275 million? So they decided to use some of that to reward themselves for doing nothing?
Ok, I can’t accuse them of doing nothing. They did let contaminated pet food make it to the shelf. And toothpaste. And cough syrup. And leaded toy trains. And either tomatoes or peppers with salmonella. And, they let China process tea leaves with a drying process that has trucks sit over the tea leaves because they dry faster under the exhaust and China uses leaded gasoline!
In addition to all of that, they kept worthy, helpful products like Provenge and Junovan off the shelf.
This is truly disgusting.
Last April I was in the FDA lobby in Rockville. Instead of medical journals and food journals, visitors and employees were greeted with a stack of Wall Street Journals. The FDA is too busy with Wall Street, no wonder it can’t get the food and drugs right! And for this, they get a bonus???? I don’t think so. This is my opinion and I am sticking to it!
Seeks The Truth
Let’s let the 30,000 men who have terminal Prostate Ca and were deprived of a revolutionary, but Big Pharma threatening, immunologic vaccine called Provenge, vote on whether “bonuses” are justified.
Von E and his minions, aided by some conflicited outsiders, oversaw the worse medical scandal I have seen in my 30 years of clinical medicine.
And nearly everyone, excepting a small but vocal group of truthseekers, continues to just LOOK THE OTHER WAY.
Shame on Von E.
Shame on his minions.
Shame on the FDA.
Shame on Big Pharma.
Shame on Scher et al.
And shame on all those who look the other way while TENS of thousands of men die every year from a common form of cancer.
John Mack
Andy just gave FDA Intern her bonus! See why he was compelled to do it: http://pharmamkting.blogspot.com/2008/07/fda-intern-gets-her-bonus.html
Dr Jonasson
Dear Sirs,
I think you missed the worst drugs of all, Darvon, Darvocet, Distalgesic and Co-Proxamol. See; http://www.youtube.com/watch?v=vw5O4tgErsg