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.
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.
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.
Fingers crossed we see approval soon!
To read the original article by the Pharmacy Times, click here.
