FDA Commish: The Agency ‘May Fail…Peril Exists’
11 CommentsBy Ed Silverman // March 27th, 2008 // 9:33 am
And Andy blames it on too many responsibilities and not enough funding. In a speech yesterday, von Eschenbach worries that the FDA “may fail in its mission to protect and promote the health of every American. Peril exists. (The agency must be) stronger, bigger and better” to continue as “the world’s gold standard as a regulatory agency,” according to Bloomberg News. Nonetheless, Andy continued, the FDA is focused on “how to manage and get out of this crisis.” And yet, he proclaimed, “the prognosis is excellent.”
You may recall that an outside panel last year issued a report saying Americans are in danger because the FDA lacks the funding to keep pace with science. The agency’s budget is more than $2 billion annually and The White House proposed increasing the FDA’s budget by 5.7 percent to $2.4 billion for fiscal 2009. The agency has insisted Andy sought more money, but never said how much. The panel believes the FDA budget will need to increase to $3.7 billion by 2013, and recommended increasing funding by $375 million to $460 million each year.
But Democratic lawmakers continue to criticize Andy for failing to press publicly for more funding. “Time and again, we have asked Commissioner von Eschenbach to tell us what he needs, but he has refused,” Congressman Bart Stupak, who chairs the House Energy and Commerce investigations subcommittee, wrote Bloomberg in an e-mail. “We have asked whether he is satisfied with the administration’s most recent budget proposal, but he wouldn’t comment.”
However, Stupak, a Michigan Democrat who has called for Andy to resign, did note that when Congress gave the FDA a $10 million funding increase, “he doled it out in bonuses to the agency’s political appointee top brass.”
Matt
It failed long ago, I think the guy is just bringing it up now to increase his budget and power.
Justice in Michigan
AVE is right about the FDA, whatever the many failings of himself and his “senior management”(who have been failing for years). I would like to see him go after the guy who appointed him too, but that is not gonna happen.
In any case, his comments should be gold-plated and installed in the front of the Supreme Court in the Fall, when they will almost certainly make this failed agency the sole arbiter of accountability in the land (via FDA preemption).
How about just one of his sentences, write huge: PERIL EXISTS.
Dan
You know, I think the last real protest against the FDA occured in the 1970s. Another one might be needed.
Chris
Without a similar size agency to compare it to, the FDA’s budget and the proposed annual increases seem extremely high. Anybody know who the outside panel is and if they have done comparable work in the private sector? As a public entity are its budgets available to examine? This seems worth further effort by Stupak.
Justice in Michigan
Chris - I posted a comparative budget summary on an earlier thread (which I won’t try to locate). By the standards of federal agencies, FDA’s is tiny. NASA is about seven times as large; EPA is larger. As you would guess, Homeland Security is 25 times as large.
Meanwhile, FDA regulates 25% of national economy.
Obviously, “right size” is in the eye of the beholder - what you expect the agency to be able to do. But every major review - from IOM to GAO to FDA’s own Science board and beyond - have reached the same conclusion. And so have people from the full spectrum of political orientations.
FDA has been starved to death for years.
Dan - I’m not sure what you mean by “major protest.” ACT UP did their thing in the late 80s. Gingrich and Co. tried to destroy the FDA entirely in the mid-90s. There have been reviews about the agency being underfunded and underpowered since it began.
Justice in Michigan
Below the comparative annunal budgets of fed agencies in 2006. Note CDER about 1/4 of FDA.
Again, “how much is enough” depends on what you expect an agency to be able to do. Anyone who has ever seen the inside of the offices where the Medwatch reports arrive - stacks of stuff lying around, in corners, on top of each other, etc. - may well conclude the way every major review has. This ain’t it.
FDA $1.9 billion
(CDER 0.5 billion)*
EPA $7.9 billion
NASA $16.3 billion
Homeland Security $49.9 billion
*of which half from ‘user fees’ (PDUFA)
Chris
That’s very helpful JiM and an eye opener. I would imagine that NASA’s and Homeland’s budgets include some form of hardware and tangible projects, programs etc that will consume significant $$$ versus a pure service function like FDA. Also interested in cost per head per group (not asking you to locate this btw) Fascinating comps all the same. Tks
Just A Thought
As much as I’d like to see the FDA do better work and have sufficient funding, it’s hard to toss more money at them without knowing they will earn it. Where is the proposed plan and will anyone make them adhere to it?
It’s a black hole for dollar dumping.
Maybe outsource the job of MedWatch report gathering to accounting firms or pollsters. Then if the FDA gets into bed with pharma where testing or technology is concerned, there won’t be a conflict of interest.
Duane Sherry
Great post - enjoyed it.
Insofar as the FDA gives the appearance of making sure drugs are safe and effective, they do more harm than good.
It’s time to move away from an all-powerful, all-knowing govt watchdog, and toward a system of information sharing - from major consumer groups and unions - that can quickly and honestly dissiminate the information…..
The courts need to sort through the damage done by Big Pharma - the death and destruction left in its path….not civil courts - criminal courts.
Duane
Lucy
The FDA Is A Captured Regulator
America finally figured out it didn’t need the Interstate Commerce Commission, our very first regulatory agency, to decide who owned and operated trucks and over what routes they were to be used. It was dysfunctional and it was disbanded. America is now figuring out that it doesn’t need the FDA to decide who owns and operates the human body and what routes are to be used fighting disease. It is dysfunctional and it should be abandoned. You cannot trust an agency receiving a large part of its funding from Big Pharma whose interests are not congruent with cures, but only with profitable palliations. Nor can you trust it not to be swayed by internal and external politics. Its only legitimate function is to opine on the safety of drugs, therapeutics, et. al. The minions of medical professionals at the FDA could then turn their skills to the treatment of patients rather than the prevention of progress, although given their collective track record they should be confined to lancing boils, albeit under close supervision.
Hard Ball
The FDA “may” fail?
Andy, get current.