These Lawsuits wouldn't have happened in the United States of America, if the FDA had stuck to its guns in the first place.
In other words, the results of the FDA approval process was no approval at all.
They turned it down.
Even though Gynecare Intergel Solution was being marketed successfully outside of the U.S. since 1998, the manufacturer had a tougher time convincing the FDA as to the merits of its product. There was concern over the potential for infection, and even suggestions that the product might prove unsafe for use by women.
"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation," the Agency's own mission statement begins.
"The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
And that should have been the end of that.
But it wasn't, by virtue of an appeals process, which allows a manufacturer to have a second go at the FDA. Not unlike the appeals process in courts of law, there is the provision which grants the right to dig in ones heals and say, "I don't agree with that." Such is the benefit of democracy.
In the end, Gynecare Intergel was approved in November 2001 through an appeals commission. The product was re-evaluated and approved as being 'reasonably safe' in the agency's view.
One has to wonder, which part of the FDA Mission Statement supports the phrase, 'reasonably safe'?
As it turned out, patients began experiencing the very adverse effects the FDA evaluation team was worried about in the first place - a situation complicated by a plethora of off-label product use for procedures not approved by the FDA. To be fair, the FDA has no control over off-label use. The latter is the sole jurisdiction of the doctor, who may in turn base an opinion on misinformation, or make a decision under influence of savvy marketing.
However, it can hardly be a surprise for a product described as 'reasonably safe' to be recalled. Either a product is safe, or it isn't. If there are side effects that are mitigated by the overall value of the drug for which it was prescribed, then it's a judgement call based on the lesser of two evils.
Compare that to, "...well, we think this could kill you. But go ahead and try it, first. We think it's reasonably safe."
In recent days the FDA has allowed limited distribution of Zelnorm, a drug that it referred to as unsafe three short months ago.
And on July 30th a federal drug advisory committee that included FDA officials gave a virtual pardon to the drug Avandia. The latter was the subject of scandalous headlines this past May after a study published in the New England Journal of Medicine linked the diabetes drug to an increased risk of cardiovascular complications.
READ MORE LEGAL NEWSIt should be noted that the FDA, once funded entirely by taxpayers and beholden to no one, is now partially funded by pharmaceutical companies.
Perhaps the FDA mission statement, and that of any publicly funded agency entrusted with a nation's health and well-being, should include some wording that suggests it knows which side of its bread is buttered.
Seventy recorded adverse affects were received by the FDA concerning Gynecare Intergel Adhesion Prevention Solution, including 48 injuries and three deaths.
It wouldn't be too much to suggest that pharmaceutical companies appear accustomed to the inside of a courtroom, when a medical product or device is accused of inuring, or killing someone.
It's a wonder more people aren't, in fact, attempting to sue the FDA.