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Is the FDA a Broken Agency?
Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.
A small peanut company's apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients. (The Chronicle, File) Some say the FDA is broken.
"Bet yourself a new hat or a fine dinner that you are going to have a scandal a month," said Rep. John Dingell, D-Mich. "They are running around like a lot of headless chickens."
Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.
"'Broken' is the kind of word that's sort of a fighting word," said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. "We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it's really hard to do the job."
Restoring the FDA's reputation will be a major challenge for an Obama administration that strode into town promising competent government.
"You've got an agency that quite frankly is either nonfunctional, or dysfunctional, or maybe all of the above," said Dingell, who as the longest serving member of the House has investigated many agencies, including the FDA.
The decline didn't happen overnight. There's no single cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. "American lives are at risk," said their report. It wasn't the first alarm.
As the pharmaceutical and food industries went global, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.
Money for research grew scarce. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.
The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.
This past year's safety problems — homegrown and imported — illustrate the FDA's weakness.
Last winter, heparin from China contaminated by a mysterious ingredient prompted an international recall. The blood thinner was triggering life-threatening allergic reactions.
Summer brought a salmonella outbreak blamed first on tomatoes and later on hot peppers as well.
This winter it was salmonella again, in peanut products. A small company's apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.
More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.
Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.
Prosecutors say hundreds of patients were sickened and five died. The feds are looking for the company's owner, who may have fled the country.
Different products were involved in the incidents, but they shared some of the same FDA shortcomings: inspections, legal authority and technology.
Although the FDA is supposed to inspect overseas plants, the pharmaceutical factory in China that made the heparin was never visited, partly because the agency confused its name with a similar name belonging to another drug factory.
The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm.
In the peanut butter outbreak, FDA inspectors quickly focused on a small Georgia processing plant. But they didn't get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meanwhile, the agency had no authority to order a food recall.
Congress has been pumping more money into the FDA. And the Obama administration seems willing to consider big changes.
The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children's cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York's health commissioner.
Baker reported from Raleigh, N.C.
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13 Comments so far
Show AllFDA, SEC, EPA, FEMA, NIH, DOJ, USDA. All broken by the Bush regime and the Clinton and Reagan administrations. All have been decimated, twisted and prevented from carrying out their original duties - having impartial professionals protect us from serious preventable injury.
It is time to replace the leadership with scientists, professionals and managers who are smart, free from conflict of interest and who believe in public service.
Joe
Hi Joe--IMO, what must happen is removal of these and all the rest of the regulatory agencies from the Executive and establishing a whole new branch of government--The Regulatory Branch--centered around the Departments of Justice and Health and Human Services, whose leaders are directly elected and endowed with some coercive power to make the other branches conform and to levy fines for violations and arrest those accused of criminal violations. Once properly staffed and funded and freed from the controlling political deadhand of the Executive, the regulators and inspectors will finally be allowed to do the jobs they ought to do to protect and enhance the lives of We The People. There also needs to be a mechanism enplaced that stops the "revolving door" existing between the regulatirs and those they're supposed to regulate.
Government can work if it's allowed to work. Currently, our whole federal government is a failure because its blueprint hasn't evolved with the times. Imagine congressional leadership incapable of keeping impeachment off the table, indeed being threatened with impeachment themselves for Not upholding their oath of office. The Regulatory Branch I'm talking about will have that power. WE must recognize that what's broken is not just the regulatory agencies, but the whole of the federal government. And every day it gets broken a little more.
Great idea... Be sure to include it in the Constitution v2.0...
I couldn't agree more. Agencies that are responsible for the public good, have failed and fallen. Our government which is responsible for the overall good of society has let us down. Everyone pays their taxes for these agencies to look over our greater good. We have been hood winked. Now this same government is telling us, for the greater good we have to bail out the large corporations that have taken advantage of the public, while government stood back and watched. Frankly, I don't see change in the near future. Government looks after "Big Business," not in anyway the general public.
karlof1 (March 4th, 2009 10:20 am) recommends "removal of these and all the rest of the regulatory agencies from the Executive and establishing a whole new branch of government--The Regulatory Branch ... whose leaders are directly elected ...."
You elect presidents. We've seen how well that works.
You elect members of Congress. We've seen how well that works.
Do you really think that creating a whole new horde of elected politicians will benefit anyone not employed in the politician-marketing industry?
On the other hand, if you clean up the electoral process, you will get proper regulation among all the other benefits.
Obviously the authors of the article are terrorist-lovin commie sympathizers.
They wish to divert a few million dollars from our trillion dollar program of killing poor brown people ten-thousand miles away to ensure our food safety!
Don't they understand these people (most of whom lack food and water security) wish to slaughter us, steal our freedoms and set nuclear devices off under our baby's cribs?
But noooo.
They're more concerned about being able to eat their food without fear of dying!
Don't they see how irrational they are?
Now eat that peanut-butter right now!...Unless you're one of them!!??
Given the atrocius cuts by the FDA for food inspections perhaps it is time for food safety to given its own entity - split it off from drugs. Then again, when we rely on, and allow, corporate America to "self regulate", we get exactly what we deserve.
The FDA was broke a long time ago the day the gave aspartame a strong "approval" and then years later banned stevia and then partially reinstated it as a "dietary supplement". The FDA has been nothing but a corporate Big Pharma puppet ever since the late 1980s !
Three years ago, the Center for Science in the Public Interest evaluated the FDA on its 100th anniversary and found it wanting:
http://www.cspinet.org/new/200606271.html
Aspartame was given approval only after Donald Rumsfeld (yes, that one) rearranged things so that it could be approved. It wasn't the "strong approval" that you say. It was a political decision.
The FDA has long been in the hands of big pharma and big food. It has been referred to as "Monsanto's eastern branch office". I doubt that any small adjustments to it will make much difference. It needs a complete overhaul.
Does a bear shit in the woods?
Reform is for the elites. Revolution is for the people.
Part 1:
Not long ago, what we as American citizens ingested in ourselves may have been at times dangerous due to flaws in the process of producing food and drugs in particular. With the absence of regulation of the manufacturers, American citizens could not be assured in what they may take to eat or restore their health was safe for them, and this was understandably concerning for many people.
Nearly 100 years ago, one man changed the fears and concerns of American Citizens regarding what they may eat, or what medicine they may be given to restore their health. And this man simply improved the way things were by writing a book.
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume. The administration was created to regulate the manufacturers who make items people do consume to ensure the safety of the American citizens.
The man responsible for the development of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book he wrote several decades ago, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. Called, “The Jungle” The one particular issue in his book regarding the lack of food safety is what caught the attention of the public who read his book, and this included the U.S. president. The impact caused by this book on others is what led to the development of the FDA.
However, and with great disappointment, the purpose and function of the FDA seems to have changed in the past few decades. The FDA appears to have decided to ensure the health of the pharmaceutical industry, an industry the FDA was designed to regulate. This is one of many disturbing flaws and concerns expressed by others regarding the FDA.
One example is the large amounts of money the pharmaceutical industry gives the FDA for various reasons created recently. These amounts of money are so large that this money given to the FDA accounts for nearly half of the FDA’s entire budget. An example of stated reason by the FDA for receiving such funds is due to what is known as the PDUFA ( the prescription drug user fee act), which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their medications awaiting approval by the FDA. The FDA also accepts from this industry over a million dollars from certain drug companies in order to give their pending new drugs a priority review of 6 months instead of a year, along with a creating an etiology for this urgency as it happens, others have said.
Results of this relationship, which some have called collusive and pathologically intimate between the FDA and the drug industry, may have something to do with the actual removal of newly approved drugs due to safety reasons. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns, one could safely say.
The FDA and the drug industry continues to attempt to validate and explain often what many others have questioned about the FDA and its lack of focus on the safety of the public- the public the FDA is suppose to protect to assure their safety. Yet the focus of the FDA and the purpose of their creation appears to be absent.
The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA announced they were allowing the pharmaceutical industry to allow their promoters of their branded drugs they market to discuss these products for disease states not studied or evaluated by the FDA. This process use to be mandatory before a drug company could claim that their drugs were beneficial for a particular disease state. Many remained shocked on this decision made by the FDA.
Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of the public health, allows for potential dangers associated with this practice. This autonomy of the FDA illustrates once again the present state of the FDA and its need for reform.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, and they do so based upon their own discretion. Historically, a pharmaceutical drug promoter was legally forbidden to suggest to a health care provider to use their promoted drugs for disease states not approved by the FDA already.
In fact, it was a federal offense for such drug representatives to speak off-label about the drugs they promoted for their employers. In the past, drug companies have had to pay settlements to the DOJ when they fractured these laws regarding off label promotion of medications.
This off-label FDA protocol for drug representatives that has been allowed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.” This overt and absurd benefit for the pharmaceutical industry is that now they can have their pharmaceutical sales representatives, unregulated themselves, speak about their promoted medications to health care providers essentially in any way they choose.
Part 2:
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss the complex considerations a health care provider is able to do because of their training.
Most drug representatives have little medical or clinical training in any objective way, and they are not hired with having such a background, usually. So this seems to further complicate the idea of this off-label authorization by the FDA due to the ignorance of the representatives to discuss such clinical matters. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to further embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them. In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of the typical pharmaceutical sales representatives that now exist. This study also concluded that around 80 percent of health care providers prefer not to interact with pharmaceutical representatives, yet still accept drug samples from them for their patients. The results are rather understandable considering what we now know.
So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association with the pharmaceutical industry by suggesting such practices that aggravate the existing situation with the lack of protection that was once offered and required from the FDA.
It is unbelievable this good reprint practices ever came into existence- with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate if not increase existing patient medication errors, such as in the elderly or dosing for children.
So there are enough problems with prescribing, and adding this FDA seems to be making the issues with medications in the U.S. worse instead of better. We as citizens are no longer the concern of the FDA, one could safely conclude, and this is clearly dangerous to the health of the public.
Perhaps another alternative would be to have clinically trained people discuss such issues regarding the benefits of medications with prescribers, instead of existing drug reps who have the sole objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part, or the consequences of their actions as they promote their drugs in this way. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain drug was initially indicated for upon approval. Yet this should not be determined by those who promote such drugs. Now, unfortunately, pharmaceutical representatives are allowed to determine how they can promote their drugs for their employer’s benefit.
Regardless, awareness needs to happen by the citizens involving these tactics progressively allowed by the FDA that are dangerous and deceptive to the health of the public. As citizens, we have the right to insist that the FDA- our FDA- maintains focus on the safety of the public and their health. Reform of the FDA appears to be necessary for this to occur to re-establish the FDA as the administration that was created for our protection, and not to protect others financially.
About half of all drugs approved presently by the FDA have had serious post-approval side effects that should have already been known or suspected of these drugs. Well over 100 thousand people die every year from drug reactions or mistakes. This seems to be a rather significant concern for those who are need to restore their health.
Dan Abshear