The Food and Drug Administration (FDA) is a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products. Health related products includes but are not limited to medicine, cosmetics, supplements, and even certain veterinary products. Their mission is to be responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.
In a nutshell, we trust them to have our back when new products hit the market.
There have always been whispers that the FDA was ignoring the risks of artificial sweeteners, that they had been bought off by the companies that produced and used them. MSG was another one that people have forever said the FDA is looking the other way despite mounting evidence that it may not be all that great for you.
Most of these claims were written off to conspiracy theorists with nothing better to do…..until now.
The FDA recently came out and admitted that 2 senators and 2 representatives from New Jersey placed undo influence on the FDA to approve a knee operation patch made by the company ReGen Biologics, which happens to be located in New Jersey. The well wishing senators claim that the money that was donated to their coffers, around $26,000, had nothing to do with the pressure they put on the FDA, they were merely looking out for a constituent company.
Here is how it went down. The agency’s scientists for years unanimously ruled that this device was unsafe due to a high failure rate, forcing the patient to have another surgery. A clinical trial of the device failed to show that it worked any better than routine surgery. That should have been the end of it, however, the agency managers overruled the scientists and approved the device for use.
The FDA’s report said that its Office of Legislation began receiving calls from members of Congress in December 2007 complaining about its review of the device, and the office’s director “described the pressure from the Hill as the most extreme he had seen.”
With all this pressure from the Congress the FDA caved and approved a device that does not appear to work. The San Antonio Spurs, of the NBA, orthopedic physician Dr. David R. Schmidt said he was involved in the original clinical trial of ReGen’s Menaflex device and concluded that patients did not benefit. He said he was surprised that the FDA approved it.
In January, the Government Accountability Office concluded that it was long past time that the agency demanded that manufacturers prove that all complex devices are safe and effective before being approved for sale.
What should we make of this? Do we need more oversight? Do we really want politicians placing calls to the FDA to approve things that shouldn’t get approved?
Hopefully in the future these agencies can stay above the fray of campaign finance and rule on things as they see fit.