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My Disruptive Relationship with the FDA Part 1

The last 18 months, I have had the amazing opportunity to see how the FDA operates in regards to drug development.

It really is amazing to witness the process. The mission of the FDA is as follows: The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

Regulating all of these elements is a tall order; managing a country that seems to want to super-size, smoke or self medicate itself out difficult situations. We have grown up thinking that there has to be a pill I can take- there has to be a cure- because there is always a cure.

To be fair; my first run-in with the FDA was 14 years ago was when Samantha was in the hospital with a form of seizures called Hypsarrythmia. Here poor little brain was seizing 90% of the day these seizures had to be stopped. We were given two options: a steroid; which would be really hard on her compromised system or a medication called Vigabatrin.

“Well let’s go with the vegamite drug.” I told our doctor.

“Vigabatrin.” She said.

“Yeah, that.”

“Well, funny thing about that drug,” she said. “It’s no longer FDA approved.”

I sat back in chair, prepared for the very worst, “Oh God,” I said. “What does it do?” I thought of all the movies about a drug gone bad that in hindsight I never should have seen.

“There are some cases where use of the drug limits peripheral vision.”

“What? Peripheral vision? So maybe she can’t catch a ball?”

“Or drive when she gets older,” Our doc said.

“Well, she is my daughter so her hand-eye coordination is suspect to begin with. As for driving, I will drive her to the moon and back. We just need to give her brain a rest.”

Our doctor agreed and for a year we smuggled contraband seizure medication from Canada. We paid out of pocket and were happy to do so. This form of epilepsy disappeared from her EEG in 8 weeks.

And so began my relationship with the FDA. At that time I was perplexed by how they deemed this drug safe or not. In my mind, the outcome of the disease was much more harmful than the side effects of the drug. In their mind, they had too many data points that said no.

As a side note, Vigabatrin is now again FDA approved and used often and effectively for this form of epilepsy. And I got to live life as a smuggler running the goods from Canada.

Win-Win, right?

But the disruption does not stop here. The FDA and their meticulous data capture and me with a knack for chaos will collide again.

Onto part two.

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