Comments on: FDA Commish: The Agency ‘May Fail…Peril Exists’

By: Hard Ball

Hard Ball — Mon, 31 Mar 2008 19:49:18 +0000

The FDA “may” fail?
Andy, get current.

By: Lucy

Lucy — Sat, 29 Mar 2008 03:42:22 +0000

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.

By: Duane Sherry

Duane Sherry — Fri, 28 Mar 2008 21:32:17 +0000

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

By: Just A Thought

Just A Thought — Fri, 28 Mar 2008 20:19:28 +0000

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.

By: Chris

Chris — Thu, 27 Mar 2008 19:49:02 +0000

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

By: Justice in Michigan

Justice in Michigan — Thu, 27 Mar 2008 19:30:03 +0000

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)

By: Justice in Michigan

Justice in Michigan — Thu, 27 Mar 2008 19:03:33 +0000

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.

By: Chris

Chris — Thu, 27 Mar 2008 17:39:30 +0000

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.

By: Dan

Dan — Thu, 27 Mar 2008 14:40:30 +0000

You know, I think the last real protest against the FDA occured in the 1970s. Another one might be needed.

By: Justice in Michigan

Justice in Michigan — Thu, 27 Mar 2008 14:27:38 +0000

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.