The FDA Is A ‘Fundamentally Broken Agency’
In fact, the agency is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators, The New York Times reports.
Computer systems are so inadequate that it can only guess the number of the plants, and can’t produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where FDA. inspections are few. The findings come from a series of reports by the Government Accountability Office scheduled to be released at a hearing at 10 am EST today of the House Energy and Commerce Committee’s subcommittee on oversight and investigations. (Here’s the witness list, and you can watch by going here).
The reports and a recent assessment by the agency’s Science Board conclude that the FDA is so overwhelmed by a flood of imports that it is incapable of protecting the public from unsafe drugs, medical devices and food. “This is a fundamentally broken agency, and it needs to be repaired,” Peter Barton Hutt, a former top lawyer with the agency who will testify Tuesday before the committee, tells the paper.
In the last 14 years, the FDA lost 1,311 employees and nearly $300 million in appropriations to inflation while Congress has passed more than 100 laws defining or expanding its regulatory responsibilities. The agency now regulates about $1 trillion worth of goods, or 25 cents of every dollar spent by consumers. And while 80 percent of the nation’s drug supply is now imported, the FDA last year inspected only 30 of more than 3,000 foreign drug plants, the Times notes.
UPDATE: During the hearing, Gail Cassell, a Lilly vp and head of the agency’s Science Board, tells the committee “we have concluded that American lives are at risk. Without urgent action, injury and death are certain.”
“I think we’ve had a cascade of serious warning signs that the levies are leaking,” Garret. FitzGerald of the University of Pennsylvania, a member of the agency’s Science Board, tells the paper. “We need to respond to these warnings before the hurricane hits.”
UPDATE: “We recognize the world has radically changed around us and we recognize we have to change and adopt,” FDA commish Andy von Eschenbach tells the committee, adding that he takes the science board report “very seriously,” but insisted the FDA still represents the “gold standard” of drug and device regulation, and said its science capabilities, while needing improvement, are “strong.”
Updates are courtesy of The Star-Ledger of New Jersey
Jack2
I agree.
I wonder if the US govt can scrounge up the extra funds from anywhere else. Is it doing anything unnecessary that costs $275 million a day?
Outside the Box
(Tongue firmly placed in cheek) Perhaps FDA could subcontract some of these inspections to the private firms helping DoD in Iraq? Given the penalty in China for illegal behavior with respect to drug supervision, they would be perfectly well qualified for on-site action, and the budgets are already in place. The only problem is that they might be too tempted to act first and inspect later.
Seriously though, I cannot imagine any Government Agency, regardless of funding, being able to effectively manage over-sight of a quarter of the entire economy. Perhaps it is time to set up separate agencies for each of the major sectors?
James
Outside the Box, I’ll take your idea and raise it–let’s have Blackwater handle the inspections. No more 483s or Warning Letters. If your manufacturing system is shot, YOU get shot. If you don’t have good CAPA, you get capped.
Insider
This is considered news? These are the kinds of problems that have been plaguing regulatory agencies for years, if not decades. It should have been obvious when the government was passing legislation in the 60s and 70s that FDA would not be able to keep up - either in the short term or long term - without substantial measures to increase support. The real story here is that the government needs to impose more taxes/and or fees on drug companies in order to offset government spending on hiring FDA employees. The big Drug companies bring in tons of money - most of it based on research funded by the government to begin with - and don’t return any of the revenue to the consumers; instead they gouge consumers with high prices. And part of the problem is with the politicians who take money from these high-powered lobbyists.
Insider
Hey Insider - this is Jack Friday (aka Insider)
Get your own monicker!
Seriously - I agree with you.
Over the last 8 years FDA has come to mean Fundamentally Defective Agency.
Let’s get David Graham in charge and have him clean house!
What does FDA stand for? | Biotech Stocks Blog
[...] Fundamentally Defective Agency [...]
AV Block
Yeah the FDA has gotten worse. It has become entangled with politics, as whistleblowers at the FDA have become rock stars over night. Back in the Mark McClellan era things were different. People at the FDA used to be objective - real scientists, worrying about things like adaptive clinical trial design.
Why waste even more taxpayer money on regulations? Truly there exists a benevolent centralized social planner.
Justice in Michigan
Throwing money at FDA won’t solve everything, but it will help. Last I check (and it’s been a while) the entire FDA budget (not just CDER) was about 2.5 bil. NASA is six or so times that. EPA is more. Homeland Security is through the roof.
Is FDA not Homeland Security?
There have obviously been terrific commissioners who took their mandate seriously and tried to get Congress to do their share - both via funding and empowerment. They have almost always failed. FDA gets a bit more authority, and Congress starves it too death. It took 20-30 years post thalidomide to set up the review system we now have. Then Newt almost succeeded in dissolving it. Then the FDAMA compromises and PDUFA. Now the FDAAA which is, at best, a question mark, and relatively tiny potatoes relative to funding, staffing, problems.
I’ve used Fitzgerald’s analogy in some of my own writing - it’s hard to resist. It is inevitable the “big one” will hit. And, if we have “FDA preemption” at the same time, it will take down not only the agency, the pharm industry, and a wide swath of healthcare, with it.
I say again: Is this not Homeland Security?
Carol
The FDA is sooo broken, and we are suppose to depend on them to keep us safe from bad drugs, medical devices, food…… They want the last say on what is safe for us and the medical device companies love it because they do not have to be held accountable for their actions due to preemption. Check out this blog. Scary!!!!
http://jaynesdays.blogspot.com/
RTW
Jack Friday - I may know you. Did ya work in A^2?
Carol - Despite the fact that everyone feels the FDA is broken we sill have the safest drug market in the world. Times change and we know so much more about adverse effects than we knew 20 years ago. Tylenol touted as the most prescribed and safest drug would probably not even make it to market today. Aspirin would have Black Box warnings on it.
People have to take some responsibility for their own health care and information. The FDA and drug industry try to scare the bigebees out of folks taking any kind of medication. Ever read the inserts. It comes down to making a rational choice which God grants us and to weight the risks individually.
Additionally, until millions are taking a drug sometimes subtle side effects will not show up except as incidental ideas from patients and maybe doctors. Proving these issues are hard and the statistics could go either way many times as it like splitting hairs. People think that everyone in Big Pharma is in it only for the money. Well the researchers down in the trenches have very altruistic ideas. They really beleive they are making the world better. To do that they require lots of MONEY, and to get that they need buisness managers etc that don’t know any thing about R&D to make the money.
The old days many Pharma where privately held companies that didn’t have share holders to placate. That was probably the golden age of drug discovery. Now even promising projects are killed if they can’t be capitalized on quickly. Its just the market forces at work.
LILI
WE DO NOT HAVE THE SAFEST DRUG MARKET IN THE WORLD. DOCTORS ARE NOT THE TV COMMERCIALS WARNINGS—TELL YOUR DOCTOR IF YOU EXPIERENCE THESE SIDE SIDE EFFECTS. TELL YOUR DOCTOR HE SAYS NO. YES THE MEDICAL PROFESSION, HEALTHCATE INDUSTRIES AND PHARMACEUTICALS ARE RUNNING THIS COUNTRY. MEW JERSEY IS THE MOST EVIL WHEN IT COMES TO PATIENT CARE. THE 2004 PATIENT SAFETY ACT WAS NOT FOR THE PATIENTS PROFESSION AND BIG PHARMA. ALL WASTING TAXPAYERS MONEY. BLAME IT ON ELECTED AND APPOINTED OFFICALS WHAT THIS COUNTRY NEEDS IS LEADER LIKE MARTIN LUTHER KING. !
RhetRx
So….could someone explain to me why it is Pharma insists that we _can’t_ trust drugs that are imported from Canada, but we are supposed to be perfectly fine with drugs that come from uninspected plants in a country that has a track record of using whatever ingredients happen to be cheap?
I would love an explanation that is based on scientific evidence rather than “one action hurts our pricing strategy and the other helps it”.
Rhet
Justice in Michigan
I totally agree with RTW re: the majority of people who work in pharma, and particularly on the science side, but not only. I’d say the same of FDA. Incredible people doing med, stat, etc. reviews. But some scuz in senior management.
As RTW suggests, there is a very delicate tipping point. But once you get there, you can take out a lot of people very quickly. A lot of this is unavoidable because unpredictable. And a lot of it is not.
When Ray Gilmartin (former Merck CEO if anyone possibly doesn’t know) visited our business school ten days after the Vioxx withdrawal (had been planned months before), he denied there was anything to learn from it at all. It was a statistical anomaly, the 18 month business, his wife took it (he didn’t assess his marriage), yada yada.
That many people go down, and there is nothing to learn? Yes, I understand that in the immediate legal circumstances, it had to be denial, denial, and denial. But I got the sense, up close and personal, that he truly believed it.
I think we need the equivalent of truth and reconciliation hearings in South Africa. It is the only way we will ever seriously address how much to know, and learn, there really is. Take liability off the table for a while. It will save a lot of people in the longer run.
ol cranky
RTW:
I’m not so sure the problems stem from companies having to placate shareholders. Even privately owned companies have a board of directors and, nowadays, the boards of the private companies are comprised of the VCs who put up the capital, who want a huge return on their investment. Very few of these have any direct experience with pharma development and little, if any, understanding of the regulations that govern the industry. Combine them with the very unscrupulous executive management who show a willful disregard to regulations and management techniques used to protect themselves under the guise of plausible deniability (& the dreaded finger pointing) and you have the mess we’re in today.
This being said, the execs still need their lapdogs and other minions to do their dirty work. Most of those people are willing participants who do get big rewards for doing their master’s bidding and many of them take great joy in retaliating against “trouble makers” who urge caution or question non-compliant activities.
SPRI
I don’t believe that the major problem is the FDA itself, although they obviously have some issues. I think that the most problematic item is that the FDA has to deal with unscrupulous companies day after day after day. These companies are always trying to get away with anything they can. If they’re asked to do a post-marketing study, they drag their feet. if a study is done and they need to report within one year, they make it two. They attempt to promote using off-label information. They push the envelope on their ads. If the companies did what they were supposed to do and could be trusted, then the FDA might be able to tackle their job.
I believe that we need to go back to the days when science and medicine drove Big Pharma companies instead of marketeers and executives driven by greed and self-interest. As it is now, the need to meet or beat the street expectations is king, but patient health should be. here’s a radical idea - control them like utilities on a national scale.
Lord Rupert Everton
Instead of controlling the industry, we need to have faith in the free market system. At the same time, we also need legislation to protect consumers and hedge against the greed of big pharma. I think it would make sense to dismantle FDA and make it private. In order for drug companies to get approval, they would have to pay higher fees based on the market. In conjunction with federally mandated requirements for private drug monitoring, government ethics and medical oversight committees would have to ensure the accountability and transparency of these private approval firms. Therefore, instead of funding a growing number of FDA employees, reduce the number to a staff of oversight commissioners that will cover private industry regulation for drug companies. It sounds crazy, but can we see a future of bigger government? Big gov only leads to more disappointment.
Justice in Michigan
Good cow, Lord! Have you been reading Newt or somethin
I never understood big gov v. small gov - just right sized gov. To (a) privatize FDA and also (b) insure transparency, have gov. ethics and oversight, clear requirements, etc etc. to me simply to create redundancy probably a larger public system to oversee the private one - and a lot of nooks and crannies where stuff could be hidden, along with a probably irresitable lures to corruption as we already see with CROS, etc..
Let’s start with an agency at least able to do the job for which it was mandated.
ol cranky
Methinks Lord is off his ever-loving rocker. Have you forgotten about the collusion in price fixing; the multiple joint development/licensing agreements; mergers & acquisitions? The free market is not really so free when it comes to prescription meds and the industry has proven time and time again it can not be trusted to police itself (mind you, the FDA has done a right crap job policing pharma too). Justice has the right idea, though I would add that we should split up the FDA so that field auditors can focus on an area of expertise.
Jaynesday
To me the trends don’t look good at all. What we want is not people being injured or killed by products that we buy in good faith. The trends are:
Adverse events continue to climb each year, including deaths.
It is documented that some Drug companies hide the bad results in their pre and post market studies.
It is documented that 1/3 of the scientists in the FDA report that they are pressured to falsify reports in an effort to get drug/devices to market.
It is documented that the FDA lacks the money, personell, computer systems and skill to protect the American public.
All of that is scary to say the least but have you heard about Preemption? Given all of the above I find it extremely concerning that we stand on the edge of the elimination of product liability if the Supreme Court rules so this spring. Preemption is based on the fact that once the FDA approves the product no further challenge to the product’s safety is allowed. Does that make any sense? You’re telling me that I should:
1. Trust the Drug/Device Companies to design, test, manufacture and market their products with safety as their number one concern not profit. Evidence says otherwise.
2. Expect the FDA to be able to insure that all products introduced for sale are without a doubt, NO QUESTIONS ASKED, safe to consume. Not going to happen any time soon.
3. Feel safe and if something bad happens to me or my loved ones in the course of using a drug/device, just accept my fate and trust that the folks did the best they could with what they had???
Justice in Michigan
Jaynesday - There has been no shortage of discussion of preemption here. Look it up on the search engine. It happens that my “moniker” is all about that as well.
Michigan is the only state in the country that has had a full FDA preemption regime for twelve years. Thus, no Michigan citizens have been able to have a day in court related to any of the drugs that have been withdrawn, or had serious warnings added, since 1996.
Add ‘em up. If the current Supreme Court rules as is most likely given recent appointees, we are your future.