Apparently, our old friends at the Food and Drug Administration are hard at work on a new policy that would affect compounding pharmacies. (These are essentially “custom” pharmacies that craft personalized prescriptions, beyond the brand-name drugs currently available on the market). The FDA’s new policy is one that would “encourage” more compounding pharmacies to register to be under their authority.
And you know what? I’m pretty outraged about it.
Some background: This all comes on the heels of a lethal meningitis outbreak, which was traced back to a New England compounding pharmacy back in 2012. Following this outbreak, Congress passed the Drug Quality and Security Act in 2013.
The goal was to give more control over compounding pharmacies to the FDA. (Prior to the outbreak, state pharmacy boards were responsible for oversight.) Under the specious premise of making compounding pharmacies “safer,” this new legislation urged these businesses to register with the FDA on their own — and those that didn’t would stay under state control, with restrictions.
Registration with the FDA would subject these compounding pharmacies to routine inspections. In return, they’d be allowed to sell their products in bulk to hospitals and physician practices — without prescriptions for individual patients.
As of today, only about 70 out of 7,500 compounding pharmacies have registered. So I realize that it may appear to the public as if the FDA is planning their new policy for your benefit. But as usual, it’s important to read between the lines.
You see, this is the same kind of situation that happened many years ago with tryptophan, an effective amino acid nutritional supplement. There was one bad batch that caused some people to fall ill. Because of the fact, this important nutrient was banned from the market for decades. (Thankfully we got it back — but it took nearly 30 years.)
But this retreading of old steps isn’t the only thing about the FDA’s latest move that doesn’t quite sit right.
For one thing, they say they are going to “encourage” registration by “adjusting enforcement priorities?” That sounds a lot like coercion to me. As in, “either you do it, or we’ll shut you down and/or make your business impossible to run.”
And it’s no empty threat. Sadly, I’ve seen it play out exactly this way more and more often in the past 5 years. These days, I’m constantly scrambling to switch suppliers in the wake of FDA shutdowns. Which, in the end, is precisely the intended result.
Because guess who uses compounding pharmacies the most? That’s right — doctors like me, in the complementary/alternative/nutritional field of medicine.
The FDA can call it whatever they like. But this is just another way to make it harder for us to do our business — which is to help deliver individualized, patient-driven care using the treatment modalities that we believe are best.
Not to mention that fact that it’ll also give Big Pharma a total lock on all the medicine that’s sold in this country. And honestly, could it be any more obvious that this is the real point of this proposed legislation?
Now, I’m not saying that the 2012 meningitis outbreak the FDA is using to justify this nonsense wasn’t tragic. It sickened nearly 800 patients across the country, and it killed 76. That’s a very big deal, no question.
But it’s nothing compared to the harm that prescription drugs cause.
Just to put things into perspective for you, someone dies of a legal prescription drug overdose every 19 minutes. Meanwhile, marijuana — a plant, which is fortunately at least medicinally legal in many states — isn’t approved by the FDA as a treatment for cancer patients. Whereas chemotherapy — which, it must be noted, was discovered through mustard gas poisoning — is FDA approved.
Call me biased, but there’s something very wrong with this picture.
At the end of the day, there is simply no reason for the FDA to be sticking their nose into state-monitored pharmacies that — minus one glaring exception — have been running perfectly fine without their interference. Especially not when they’re failing so miserably at the one job they already have.
The only bright spot in this story is that, for a change, I am not the only one slamming the FDA over their latest intimidation tactic. The American Pharmacists Association has also accused them of overstepping their bounds — though unsurprisingly, they show no intention of backing down.
It’s par for the course for this current government administration. And once again, there’s no telling how long it will take for the damage to be undone.