Health

FDA Approval, The Dated Method That’s Caused Pain And Casualties In The Name Of Money

By Gwen Farrell··  6 min read
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shutterstock FDA Approval, The Dated Method That’s Caused Pain And Casualties In The Name Of Money

You would have to actively not be paying attention to not notice that the Food and Drug Administration has been in the news lately…a lot. They’ve been the governing force on what we put into our bodies for some time now, and the gold standard for what many judge to be safe.

Not to mention, they generate considerable money for say, pharmaceutical companies, and other related parties. The FDA stands by what they bill as a rigorous and thorough testing standard by which products receive their stamp of approval. As it turns out, that dated method has pretty much been responsible for countless deceptions, lies, and casualties, all in the name of money.

Medical Devices Aren’t Held to the Same Standard

A medical device is any accessory manufactured for medical purposes. The FDA categorizes medical devices into three distinct types: class I, which includes bandaids, gauze, and wheelchairs; class II, which encompasses devices like a catheter or a CT scanner; and class III, the category which includes the items we traditionally think of when we think of medical devices: pacemakers, breast implants, cochlear implants, ventilators, and prosthetics.

The FDA prides itself on being the central regulatory agency when it comes to medical devices. As they claim, there’s a “risk-based tiered approach” for regulating and approving devices. But you probably didn’t know that medical devices aren’t subjected to the same approval standards that other products are. While drug approval necessitates, at a minimum, two studies, devices only need one. Additionally, device manufacturers can employ policy Section 501(k) of the Food, Drug, and Cosmetic Act, which allows products to skip the normal standards review if the device is “substantially equivalent” to one that has already been approved.

While drug approval necessitates, at a minimum, two studies, devices only need one. 

In 1976, the FDA took over the process of approving medical devices. Surprisingly enough, this included the devices which were on the market before they took over, and due to a Congressional loophole, even products that were previously recalled were approved under a policy called the “premarket approval program,” which is covered extensively in the Netflix Original documentary The Bleeding Edge. Needless to say, a lack of oversight and investigation into premarket devices, as well as laxer standards on devices versus drugs, built a tinder box of potential disaster, the bare minimum of which is touched on in the documentary.

Protecting the Big Names

Because FDA approval is treated as the gold standard when it comes to what we deem “safe” or effective, this can mislead consumers into using harmful products at the expense of their health. 

Just one example of this is Johnson & Johnson, a global brand that manufactures and markets everything from Covid vaccines to blood thinners to baby shampoo. Johnson & Johnson has faced a whole litany of product-related lawsuits in recent history, yet all of their products on the market have to be FDA-approved to even be available to consumers.

In 2019, Donna Olson, a mesothelioma patient, was awarded $300 million from Johnson & Johnson in compensatory and punitive damages, after she discovered her diagnosis was associated with the brand’s talc powder and pursued legal action. Despite what, to most people, is an incredible monetary settlement, in reality, it’s nothing in comparison with the company’s annual earnings which are worth billions, especially with their development of a sought-after vaccine.

J&J has faced a whole litany of FDA-approved product-related lawsuits in recent history.

Then there’s Essure, a birth control implant device manufactured by Bayer that was discontinued in 2019. Users of Essure quickly found themselves suffering from bleeding and persistent pain, fallopian tube perforation, and some even died. The device was approved by the FDA in 2002, but by 2018, the FDA encouraged Bayer to pull the product from the market. Bayer did so only under the explanation that its removal was due to a decrease in sales, and not because it was damaging the bodies and lives of women. 

But those women only had availability to Essure in the first place because it was stamped with the FDA’s approval, ensuring that it was safe and effective for them. While it may seem too much to demand that the sole governing agency over these products have the foresight to prevent these kinds of instances, it’s also the bare minimum for an institution that supposedly thrives on transparency, accountability, research, investigation, and safety.

What This Means for Us

You might be taking in this information and thinking, "Great. So what?"

We’ve had all manner of official government agencies claiming that they know what’s best for us over the last few years. They tell us what to put in our bodies, what not to put in our bodies – and they encourage policymakers to threaten our livelihoods should we even question their legitimacy.

The FDA can approve or reject whatever device, product, or drug they want by their own standards or guidelines. In reality, as we’ve seen from just a handful of instances (when there are so many more out there), there is no real guarantee, not at all. No stamp of approval or shiny badge of a government agency’s support really means anything, compared to how a product may affect your or your family.

The FDA can approve or reject whatever device, product, or drug they want by their own standards.

In reality, this discussion isn’t just about vaccines, and it didn’t start when they were rolled out or when they received FDA approval. Lack of oversight for harmful products goes back decades. In the end, the companies end up paying and the unfortunate people end up suffering for the rest of their lives, while the Food and Drug Administration – who approved the product in the first place – is free to carry on dictating what’s safe and what isn’t.

Closing Thoughts

For some, FDA approval is the guiding principle for what they put into their bodies. For others, it’s just another arbitrary government regulation.

The thing is, there isn’t a lot of oversight or accountability when it comes to their approval. What’s approved one day could be swept off the shelves within a couple of years, and most of us are none the wiser. Unless we’re one of the individuals whose futures are forever changed by something that was once approved and then later determined to be dangerous. 

Somehow, this distinction hasn’t really made it into our mainstream conversations on the vaccine. But if history has shown us anything, it’s just a matter of time.

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