FDA is Understaffed, Underfunded, and Can’t Handle Food Inspections

Mike Ferrara
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Posted by Mike FerraraJanuary 25, 2009 12:02 AM

This week, Dr. Steven Nissen, the current chairman of cardiovascular medicine at the Cleveland Clinic who may soon become head of the Food and Drug Administration under President Obama, said that the FDA is not equipped to handle the increasingly complex processes of inspected the United States food supply.

According to Nissen, the enormous tasks involved in approving medications and medical devices have swamped the FDA to the point where it’s lost control of the food situation.

"The truth be told, the FDA is a failed agency . . . the main problem is that it is terribly underfunded," Nissen said. "It needs to do more inspections, especially of foods brought in internationally. We are all very vulnerable. This has to be fixed and fixed quickly."

Nissen is no stranger to speaking out against the FDA and has garnered the spotlight for occasionally taking the agency to task, even while serving as a committee member on high-profile FDA drug panels.

He is widely known as a physician-activist and doesn't mind taking heat from drug companies when he finds deadly flaws in their products. –Delthia Ricks, CNN


As more and more food is being imported to the United States, more inspections are needed to ensure that products like the recent melamine-tainted milk and infant formula from China don’t make it onto American store shelves. At this time, much of the food brought in from abroad isn’t FDA-inspected at all.

Nissen, a long-time proponent of drug safety, voiced early objections to the Merck drug Vioxx, arguing (quite correctly, as it turned out) that the drug caused heart attacks. Accordingly, Vioxx was taken off the market in 2002. In 2007, his warnings that the diabetes drug Avandia could also cause heart attacks led the FDA to give the drug the black box warning label it carries today.

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Trudy B Crookshank
Posted by Trudy B Crookshank
January 25, 2009 2:49 PM

Re:Dr. Nissen,
I have notified the FDA as well as Bayer Pharm. to voice a formal complaint of the known potential of the toxic drug AVELOX. It has caused permanent injuries,such as mine, which include seizure disorder(never experienced before Avelox),reactive-airway disease/asthma(never had before avelox)loss of gag reflex bilaterally since anaphylaxis/laryngospasms,cognitive impairment,new acquired allergens(dogs,cats,perfumes,mold,pine trees). I always had a pet dog.Now i can,t stand to visit my 3 grandchildren because they have 3 dogs which cause me great distress(wheezing,diffuse itching,hoarseness,severe headache) My vision has suffered to the extent i am afraid to drive at night so i don,t. I,ve had 2 eye exams since the Avelox toxic event stating i fear i,m going blind! An MRI was ordered to visualize the optic nerves because my visual field is so small and appears gray. I also see opaque tailed objects in my visual field everyday. This frightens me the most. Fear of blindness. I received 6,900 AERS from the FDA FOIA in 2005. I only wish i could sue the FDA as well as BAYER, for not protecting thousands of consumers,now victims,from limited trials , which has permitted Bayer to profit from this KNOWN toxic drug!! Shame on Bayer and the FDA. Class-action lawsuits against Bayer should have been filed in 1999-present. Tis drug should have NEVER been approved for marketing!! Does anyone actually record or read the thousands of AERS(complaints) that are sent,emailed to the FDA medwatch as well as BATER. A report number is assigned by both and that,s the END of it!!!
I,m damaged but i,m angry as he--,and i won,t stop fighting Bayer and the FDA.I know you can,t trust many physicians because of their greed. Pharmaceuticals offer "incentives" to keep prescribing this toxic drug when they know there are safer antibiotics to chose from. The price of Avelox is outrageous!! I wonder why?Multimillions are being profited while consumers suffer and some DIE!!

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