The Food and Drug Administration Informative - Warning: FDA so underfunded, consumers are put at risk

Review by 36356 on 2007-12-03
The Food and Drug Administration is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety, an advisory panel to the FDA says in a report to be discussed Monday.
The report — developed in the past year by experts from academia, industry and other government agencies — delivers a scathing review of the state of the FDA, which regulates 80% of the nation's food, its drugs, vaccines and medical devices.

The report details a "plethora of inadequacies" in the agency, including:

•Inadequate inspections of manufacturers, noting that foodmakers, for example, are inspected about once every 10 years.

•A "badly broken" food-import system and food supply "that grows riskier each year." In the past 35 years, FDA inspections of the food supply have dropped 78% due to soaring numbers of products and inadequate FDA funding.

•A depleted FDA staff, which is about the same size as it was 15 years ago despite huge growth in agency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.

•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.

•An "obsolete" information-technology system.

The report says that the FDA's IT systems are so lacking that reports of product dangers are not rapidly compared and analyzed, and that inspectors' reports are handwritten and slow to move through the system. The IT systems have resulted in lost FDA data and lack backup systems. "Piles and piles" of paper documents are in warehouses with no backup, including clinical trial data.

The report echoes concerns put forth before by others, including the Institute of Medicine; the Government Accountability Office, the investigative arm of Congress; and congressional committees.

Previous reports by FDA advisory boards — which are made up of independent experts — have voiced similar concerns, the report said. But those boards warned that crises would arise if funding issues weren't addressed, the report said. "Some of those crises are now realities, and American lives are at risk," the report said.

The advisers traced the long list of ailments to chronic underfunding and a continual expansion of FDA duties. While the FDA regulates 80% of America's food, it receives about one-third of the nation's food-safety budget; the U.S. Department of Agriculture gets the rest.

Many, including industry groups and some lawmakers, have pushed for greater FDA funding. The Coalition for a Stronger FDA is co-chaired by the last three secretaries of Health and Human Services, which oversees the FDA. The coalition says the FDA needs a 15% boost in funding per year for the next five years.

The report, "FDA Science and Mission at Risk," says all estimates so far are too low. It says U.S. consumers pay about 1.5 cents per day for the FDA and that 3 cents per day would not be "a great price to pay" to ensure food and drug safety.

The FDA declined to comment on the report, which will be discussed today at a meeting of the full science advisory board, of which the subcommittee that wrote the report is part. The FDA has said it won't make any immediate changes based on the report. In addition to advocating for increased funding, the report recommends that the FDA, among other things, invest in IT, centralize science programs, create new science directors and hire more high-quality talent.

The subcommittee included: Allen Roses of Duke University, an expert in neurology; Gail Cassell, a vice president of Eli Lilly; and Barbara McNeil, a public health policy expert at Harvard Medical School.

William Hubbard, a former FDA associate commissioner who supports the Coalition for a Stronger FDA, says the report stands out because of the "intensity of the feelings" expressed by the subcommittee.

"These people were horrified by what they found," he says. While the subcommittee was supposed to look ahead to where the FDA needs to be, Hubbard says it came away concluding that "it cannot even do its job now."
Comments:12 Replies - Latest reply on 2008-01-15
Posted by Dan on 2007-12-03:
I've worked in the pharmaceutical industry now for 10 years and I can attest to the fact that the FDA is very much underfunded and also not properly trainined in new technologies. I've been involved in audits where the inspector has no idea about how some of the new complex lab software works and basically just rubber stamps the pre-approval inspection report because he/she doesn't even fully understand what they are looking at. At one of the smaller generic company's I worked at, there were so many glaring violations that were obvious to even people new in the industry, but they were routinely overlooked by inspectors either due to lack of training/knowledge or being so overworked they were in a hurry to get to the next company.
Posted by MRM on 2007-12-03:
Thanks for informing your un-informed readers, superbowl.
Posted by D. on 2007-12-03:
"underfunded and understaffed"....perfect solution: Hire the illegals...they take the jobs cheap that the American's don't want!
Posted by Anonymous on 2007-12-03:
We shop a lot at Whole Foods Market now. We figure we stand a better chance of not getting anything toxic in our food. We also try to use only all natural vitamins and stuff, less toxins, poisons, lead etc to have to deal with.
Posted by Anonymous on 2007-12-03:
DB, we can't hire the illegals! They are to to busy sneaking all the bad stuff and drugs in.
Posted by D. on 2007-12-03:
Uncle Sam should charge tax on drugs...people make quite an income with them! They've already talked about taxing prostitution, why not drugs?
Posted by D. on 2007-12-03:
Posted by Anonymous on 2007-12-03:
DB, Uncle Sam already charges taxes on drugs, legal and illegal drugs. When someone is busted for drugs the first people that show up are from the IRS trying to make people sign a paper stating they owe a minimum of $25,000.00 in taxes and more if convicted. It's a neat little racket they have going on because in doing so they are in fact saying the person has legal income they didn't report.
Posted by Anonymous on 2007-12-03:
This is typical of what happens when the Federal government takes it apron it self to endow it self with this kind of power. This should be a privately run organization monitored by privet citizens.

What about the Pure Food and Drug Administration?
There is no authority for this agency under the Constitution. If it is in the national interest to have such an agency it should have been authorized by an amendment. There is already a wide-spread criticism of the arbitrary manner in which this agency has exercised its broad spectrum of power.

What about Consumer Protection?
Here again we have an exercise of power unauthorized by the Constitution. Do we really want that much power allocated to the federal level where the agency is so big and powerful that not even the largest corporations are able to cope with its abuses?
Posted by Anonymous on 2007-12-03:
Good points Lid's, and we the consumer will bear the brunt of the fallout for the FDA being a crap shoot about doing their job.
Posted by ebay_ball_buster on 2008-01-15:
Thanks for the information SuperBowl. After reading your postings I find you have a lot to offer.

I have first hand experienced the screw-ups or lack on monitoring and information be provided by the FDA.

When I was 10 I was diagnosed as having bi-polar. I have been given so many drugs over the years that I know more about most drugs than my pharmacist, PA's and General Practitioners (MDs). One of the drugs I was given was Tegratol. By the time I was 16 I had cataracts removed and again at 18 had cataracts removed. 2 years later (6 years after starting to take this drug), a ophthalmologist recommended they should remove me from this med because it can cause cataracts.

On with my life - I now have cataracts removed about every 5 years and they can give me no other reason than the levels of Tegratol I took for so many years.

Another situation was when I had become unable to move without excruciating pain. This went on for years to the point that I could not flush the toilet or pick up a glass of water. Eventually a tox-screen showed that I was being poisoned by aspartame found in every diet drink and every low cal product on the market. I eliminated diet soda from my diet and every other product with aspartame and for the first time in 3 years I was able to get out of bed. When testing for aspartame you can still find it in my system, I guess it never completely leaves the same as heavy metals, and other poisons.

During this time I was given Ultram because it was non-addicting. When the time came that I had maxxed out on the "safe" dosage they discovered that I was physically addicted to the medication. So much for a safe pain med. Though the withdrawals were not what I expect a heroin addict goes through, non the less I was very miserable and had to be hospitalized during this withdrawal to do it safely.

The latest was during this last year when I was being given Rozeram with a combination of other antidepressants and pain medications. I kept finding my memory slipping more and more. I would forget to get my son from school. I would forget that I promised to be somewhere. I would forget that I had talked to my mom 5 minutes before. I kept complaining to my doctor and the pharmacist who would ask if I was exaggerating the situation or ask if I was getting enough sleep. The final straw was the day I was driving down the road from my home to my sons school. All of a sudden I did not know where I was, where I had come from or where I was going to. I was truly terrified and had to finally admit I was forgetting things. Mind you, I have been traveling this road regularly for 42 years. I had to dial 911 and tell the operator I had no idea where I was, please help me! Thank goodness the officer who arrived was a neighbor and because I did not have my son with me and didn't remember getting him, he guessed I was going to go get my son from school because of the time. He went and got my son, called my mom and she got my car because no one felt safe letting me drive. LOL "I wonder why???" So off to the hospital I went again. Only at the hospital in the psychiatric unit did anyone realize that amnesia was a side effect of Rozerem in some people. Two days not taking it and my memory was sharp as a tack.

The most recent screw-up, just two weeks old now - Back to the diagnosis when I was 10 of being bi-polar. I have now been re-diagnosed. Even though I have a very high IQ and present as a very intelligent person, I have now been re-diagnosed as having had brain damage. It has many of the same symptoms as bi-polar but is treated with a whole different class of medications.

When I was 10 I went camping with my family. There were horses in a pasture and me and two boys went and were riding them bare back. I ended up connecting my forehead with a branch at a full gallop thus falling under the horse and receiving a hoof in the back of the head. I was unconscious for about 30 minutes and the boys brought me back to the cabin and I went to sleep for two days telling my mom I fell out of a tree. She figured I was just fine and then later I told her I was feeling queasy and she figured I had the flu. I didn't tell her about the head injury from the horse because she had told me to STAY AWAY FROM THOSE HORSES. She just learned the other day what had happened for real all those 32 years ago. She asked why I hadn't said anything and immediately I was that 10 year old little girl not wanting to get in trouble. What a shock to find out that my whole life had been a lie and a daze because of one little omission of the facts.

At the most I was taking 27 meds at one time including thorazine, you know the one from "One Flew Over the Cuckoos Nest". Most of the meds were to stop side effects not to help my symptoms. Even the ones to help my symptoms never would have worked because they did not have a correct diagnoses.

I guess after all this rambling the real point is put as few medications, preservatives, chemicals, and altered foods into your body as possible. Take charge of your medications if you do need to take them and don't blindly follow your doctors lead. He/She may mean the best but they only have as much information as the drug companies give to them. The drug companies are not required to give all tests to the FDA the are only required to give a certain amount of tests. So if the drug company does not get the results they want they do change the parameters of the test and say the FDA requires 15 tests that prove the drug is safe. The drug company gives them 15 tests that show the results they want. That doesn't mean the drug wasn't tested 50 times. There is also a threshold on the reporting. Such was the side effect of cataracts with Tegretol. The percentage of people who present with side effect was so small that the FDA did not require the drug company to list it as one of the side effects. It was only because my ophthalmologist had put 2 and 2 together with other patients because he always READ the medical histories and medications and asked about medications taken over the previous 5 years that he knew to even ask the question.

Thank you SuperBowl - hopefully others will read your post and take it seriously.
Posted by Anonymous on 2008-01-15:
thats our Bowl...he is Super

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