FDA....heavy sigh
Why they no longer work in the interest of the actual recipients of medications
Y’all know I’m a vet if you have read all 2 of my
posts. In my profession, we have many issues. One of the most challenging is appropriately treating the wide variety of animals and conditions we see every day.
I don’t do exotics per say, so I am spared trying to medicate birds and most pocket pets. I also don’t do reptiles. But I do see dogs, cats, horses, goats, pigs cattle, rabbits and the occasional chicken. Diagnosing them is hard enough. Even though most are mammals, their organ systems can vary widely from species to species. Cats are not small dogs. Horses are not fast cows. They all have systems and diseases unique to their species. That is our first challenge. Once we have a diagnosis, comes our second challenge.
There are woefully few drugs FDA approved for animals. Only the money makers ever get approved. Flea pills, heartworm preventatives. Maintenance meds that mead a stead stream of income for the manufacturer. Very few antibiotics, heart medications, etc are labelled specifically for animals. It’s OK though, we are permitted, as a profession to exercise our judgement and do off label prescribing. The FDA understands, or used to, that we have very little at our disposal and so it’s OK for us to prescribe drugs not specifically labelled for our desired use as long as we can reasonably justify it.
Now, in comes compounding. I graduated vet school in 1996. Back then a few local pharmacies compounded medications. Compounding means reformulating active ingredients into another form, say liquid or into combinations not commercially available. To be clear, vets are permitted to ‘compound’ concoctions on our countertops and many do. They mix things together and form potions that may or may not be useful. No one ever complains about that.
Compounding pharmacies have recently gained a lot of popularity in veterinary medicine. They provide us with products that are more useful….like liquid or transdermal preparations for cats instead of pills(I mean…can you say stupid?). There are good and bad compounders. Several years ago a couple dozen horses were killed by an improperly compounded supplement. They are fallible and make mistakes(so does Big Pharma BTW). There are some very reputable ones as well. Wedgewood Pharmacy, which I visited in New Jersey is an amazing operation. Clean, organized impeccable. I order most of my compounding needs from them. They do a great job. I have never had a bad product come from them. Things were all going great until a couple of years ago when the FDA was pressured by someone—give you two guesses and the first don’t count….to rein in Compounders.
Well, you would think they would achieve this by inspecting the pharmacies and their procedures and shutting down the shady ones. Silly you. No, instead they came up with GFI #256. GFI stand for Guidance for Industry. #256 is Compounding Animal Drugs from Bulk Drug Substances. This little dandy has come up with a list of acceptable and not acceptable compounded medications we have available to us. And it gets more complicated than that. State Boards of Pharmacy generally determine further IF vets are even allowed to use compounded drugs at all. Literally each state has it’s own rule book for these things…and the rules vary greatly. For example, in my state, we are not allowed to have compounded controlled substances in our clinic read to dispense when the patient needs them(most controlled drugs are for severe pain, keep that in mind), but we can script them out and make the patient wait days for their medications. Many states allow full access to ‘office use’ compounded medications, meaning you can order compounded formulations and keep them in house to dispense on the spot as needed. This comes in very useful for 4lb kittens that would be poisoned by dosages of some medications.
We were limping along OK with this system until someone at the FDA, at the urging, no doubt, of someone outside the FDA(once again, you get two guesses who) decided that we shouldn’t be able to have anything that might have a proprietary equivalent, EVEN if it’s inappropriately concentrated or hard to give(see pills for cats).
Now there is a list that literally changes every week or so telling us what preparations we are permitted to have in our offices to help our patients with. Some of these we have been using for 10 years or more with no ill effects, EXCEPT potentially to the bottom line of you know who. You can petition the FDA to consider a preparation based on unique need, not proprietary equivalent, things like that. But don’t you DARE say you need compounded medications to help the client afford treatment. That is verboten. Above all is protecting the patent rights of the branded medications. They don’t even really hide that. And of course…..it’s all being done for ……ya ready for it? SAFETY
So, if you go to your local vet and are no longer able to get that liquid for your cat and they send home with pills instead, you can just send your OWN medical bills for cat scratch fever to the FDA, because they will be the proximate cause…..