GFY, FDA

The FDA routinely makes people less safe and less well-off. My family became direct victims of their ridiculous antics, but thankfully the increased risk was not borne into permanent disability.

FDA Commissioner Margaret Hamburg led a hearing on drug shortages in 2012. She appears to be in deep thought, wondering why FDA limiting access to drugs would lead to drug shortages. Now, in 2023, drug shortages are worse than ever. Unfortunately, for all her deep thought, the idea of abolishing the FDA never crossed her mind. Our loss. // photo by the FDA

My wife and I had another child recently. This time, through surrogacy.

This, of course, triggered all kinds of legal issues and we were slapped with the FDA not once, but twice.

The first time was way back when we were looking to get aligned with a surrogate. We already had embryos as our son already was an IVF baby and we were trying for another. As the embryos following my son's birth failed to take, we turned to surrogacy. One of the conditions of surrogacy, as directed by the FDA, was for both people that will be the biological parents to go through testing.

This makes sense.

If you don't already have embryos.

Since our already-tested embryos were already in storage and we would not be making any new ones, that made this exercise completely absurd and unnecessary. But it's what the FDA deemed must be done.

So one morning, I took the morning off and drove almost an hour in the opposite direction from work, toward the clinic, and saw the doctor that would perform the test. The first thing the doctor said to me was that yes, it is ridiculous that I had to go through this. He asked me a few questions, rubber-stamped the red tape, and I was pretty much on my way. But not before paying him about $250 on the way out for the experience.

The second time happened when our surrogate was already pregnant and heading into the third trimester. My wife wanted to breastfeed and there are drugs that trigger lactation for women. So her doctor prescribed medication from Canada because the FDA did not approve it for use within the United States. Sigh.

Whatever. She ordered it from a Canadian pharmacy and had it delivered to our house. It went swimmingly.

Then the next shipment was delayed. In a panic, my wife ordered another set, thinking she forgot to order it. Shortly after, we received a letter from the FDA stating that they had confiscated the second shipment.

In the letter, they iterate and reiterate a few times that the FDA protects American consumers by ensuring the drugs are safe and effective. The constant reminder was understandable since their actions probably piss off a lot of people that need their medication.

It's all bullshit.

In the appeal, one must cover all points listed. Among them, one is: 

The drug must be unapproved and intended for use in a serious medical condition for which there is no effective treatment domestically available.

If it's all about safety, why does it matter that there is no effective treatment domestically available? If a drug has undergone appropriate clinical trials, what does this matter? Assuming only one body, the FDA, can understand benefits and risks, and is all-knowing, would be a fantastically naïve outlook on how the world works.

Another:

There must be no commercialization or promotion of the drug in the United States - Your product does not meet the requirement as it can be purchased in the US.

This is just blatantly a protection racket for domestic pharmaceutical companies. Whether a drug is available or not for purchase in the United States or not is entirely irrelevant. It's not like we're buying drugs from the Mexican drug cartels. We're buying it from a legit Canadian pharmacy. This drug is also used by millions across the globe. Also, no, the drug we are buying isn't available for purchase in the United States, unless the FDA knows of some tiny mom-and-pop shop in North Dakota somewhere that sells it for whatever reason, but they weren't offering to share the information on where the FDA had unbanned the drug as if geography makes drugs safe.

These two protection racket items were the first two listed. 

The last one:

The request is generally for no more than a 3-month supply of the drug.

What in the hell does this matter? If it's been established from the above that it's safe, why does it matter that it's for no more than a 3-month supply? Again, the only reason I can think of is that this helps protect the financial interests of major local pharmaceutical companies as complications from nontreatment could mean a patient victim would have to buy more expensive local drugs. That, or the FDA is ridiculously incompetent.

Our appeal was, unsurprisingly to me, denied, even though we really do meet each item on their list, except maybe "serious medical condition", but what the hell does it matter how serious the condition is, if the drug is safe?

Upon our appeal, the FDA responded that there have been known cases where people have died following taking the drug.

Yeah, there have also been cases where people died after eating peanuts. Are peanuts banned?

Looking into it, these cases are incredibly rare and pretty much always accompanied by the patient having cancer or leukemia, or some other comorbidity, none of which my wife has.

So my wife had to go back to her doctor and tell her what had happened. The doctor rolled her eyes, had some not-so-kind things to say about the FDA's ruling on this drug, and prescribed her a different drug that is FDA approved, for lactation. The doctor said she doesn't like to prescribe this drug because prolonged use of this drug (a supply of a few months) can have side effects like persistent muscle spasms that can be permanent. These side effects actually would affect my wife since these effects are not accompanied by comorbidities.

Thankfully, not too long after, the third shipment of the original drug had been missed by the FDA and arrived at our doorstep.

Essentially, the FDA forbade my wife from taking a safe drug, instead forcing her to take a less safe drug, while trying to tell us they do this for our safety.

Go fuck yourself, FDA. Go fuck yourself in the left ear with that needle dick far enough that it punctures the part of the brain that causes your stupidity. Then fuck off.