Is the FDA Ruining Your Chances of Being Treated?

The FDA: created to protect public health consumers by assuring the safety, efficacy, and security of medications, devices, food, cosmetics, and other products. No, I did come up with that myself. That was taken straight from the FDA’s fine website.

The FDA is also responsible for approving YOUR acromegaly medications. That’s right—and if you didn’t know that, it’s time you moved out from under your rock.

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Move out, no matter how nice your rock house is! Source: www.giphy.com

So, yes, while the FDA does protect your rights as a “public health consumer,” they also tend to come between you and those potentially life-saving medications. How? Well, all drugs, medications, and therapies MUST go through a clinical trial process in order to get approved by the FDA.

Otherwise, you might end up taking a drug your weird neighbor made in the basement of his house with his best friend from high school.

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Source: www.giphy.com

So, you know what? The FDA really is a good thing… It’s just hard not to get frustrated when it delays the approval of a medication you’ve been watching in clinical trials because there just isn’t enough efficacy evidence.

Such is the case with Mycapssa, a maintenance treatment for people suffering from acromegaly.

It had been through many a clinical trial, and yet, Chiasma (the manufacturer of the drug) got a letter from the FDA in April rejecting approval. Yikes! Mark Leuchtenberger, president and CEO, said:

“We… respectfully disagree with the FDA’s decision.”

Yup, that’s a respectful way to put it. But, per the FDA’s request, Chiasma will continue to conduct trials to gather more data.

movies the avengers samuel l jackson nick fury
Pictured: What Chiasma wishes they could do instead. Source: www.giphy.com

Fingers crossed we see approval soon!

To read the original article by the Pharmacy Times, click here.


Lady Kehveen Abernathy

Lady Kehveen Abernathy

Lady Kehveen Abernathy, of noble birth (or so she’d like to believe), is what many would call a youthful “old soul.” As a self-proclaimed “caregiver to the world,” impassioned about life, triumph, and all things beauty, Lady Kehveen strives to love others, seek understanding, and most importantly, spread awareness. But don’t let her sweet demeanor deceive you. Dressed to the nines over corset and petticoat, she’s made it her mission to defend the innocent and fight all things evil on this Earth. And being no stranger to chronic disease, she knows exactly where to start.

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