So, does all this mean that the compounding pharmacies have all been busy making “unapproved” drugs? In wildly varying doses? I understand the justification for this whole fiasco. But it still makes no sense. In a more paranoid mindset I would be inclined to think this was just a big gift to KV from the FDA for no purpose but to enrich them since the need for progesterone injections was already being addressed by the compounding pharmacies.
From this morning’s news:
I consider myself one of the more liberal leaning members of this Board and I have no problem blaming most of society’s ills on Republicans but even I can’t bring myself to lay the blame at their feet on this one (unless we do a Six Degrees of Separation thing to make it that it is Republicans who created the environment this happened in…I’m not going to try though as it is a reach even for me).
Well, I’m pro-abortion rights, so I won’t comment on this, but this is definitely not the free market at work.
As Bricker kindly points out, the FDA is chock full of democrats right now, including the ones that granted this monopoly. Frankly, from what I know of the Orphan Drug issue (which is admittedly not that much), the FDA powers in this case are contrary to patent law (e.g. the case of obviousness, new, and the existence of prior art being the most contrarian), though the FDA monopoly is only 7 years as opposed to 20.
Even my most conservative doctor friends admit that the Orphan Drug issue is something that needs to be addressed by the government. The issue is that doctors know of compounds that will/should cure ailments that affect a small percentage of the population, but because of the lack of a large enough sample size, proper tests cannot be done. I think it is admirable goal of a society to not experiment on its populace, but I digress… The point is that before the monopoly there were no standard manufacturing of KV’s drug. I’ll assume that KV jumped through the right hoops to get this monopoly, but I’ll be interested to here where they were lacking.
So, assuming is everything is kosher up to this point, the last issue that remains (mind you, I only skimmed the Orphan Drug Act) is if there are more than 200,000 people affected by this (200k and under was the number in the Act). I know the percentage mark-up seems ridiculous, even I had that initial gut reaction (as my company doesn’t even charge that much markup on its patents). But, we should look and see what other alternatives exist, and we should see if this affects more than 200k people.
If more than 200k, then this action flies in the face of the letter of the law and the monopoly should be revoked. If many alternatives exist, especially cheaper ones, that what is all the outrage over?
Not bad.
Not oerfect – the correct manuever would be to revoke the exclusive license – but I agree this is a good solution to the problem.
And I lay the credit for the solution at the feet of Republicans, because the FDA was created by law signed by Republican President T.R. Roosevelt.
I kid, of course.
The FDA is controlled by Democrats. They get the blame for the problem and the credit for the solution.
Nobody’s oerfect!
Especially in my oeuvre.
This is about good medicine and bad laws.
A physician may legally give any patient any drug they wish if the drug is legally on the market, even if the drug isn’t licensed for the condition the doctor wishes to prescribe it to treat,*
if there is no equivalent licenced drug for that specific indication.*
So, if you have Rare-as-hens-teeth Syndrome, which I, as your physician, know will be cured by a daily dose of Cure-it-all, a popular and cheap indigestion remedy, I can prescribe you Cure-it-all.
This is known as “off-label” prescribing and is done all the time.
HOWEVER
The manufacturers of Cure-it-all discover that Rare-As-Hens-Teeth Syndrome responds to their medication, and re-brand it as Cures-Rare-Syndrome, with a new packaging and a different dose, and get a licence that now covers it as treatment for Rare-As-Hens-Teeth Syndrome.
Cures-rare-syndrome now costs 1500 times as much as Cure-it-all, despite being exactly the same thing.
It now becomes illegal for a physician to prescribe Cure-it-all for RAHT syndrome, when there is a licensed medication for it- despite that medication being essentially the same, but for price.
Crazy, immoral and a serious flaw in Orphan drug legislation.
The British Medical journal did a series of articles on this in November 2010. They are worth reading.
So if this drug has been around for ages, why isn’t it available as a generic?
Indeed; it’s exactly like that.
You guys really have no idea how government agencies work at this level. The people who made this decision aren’t specifically Democrats or Republicans. They didn’t choose to work for the Democrats anymore than I chose to work for George Bush when I started my NIH position 10 years ago. They are highly trained but underpaid physicians, statisticians and bureaucrats who were doing their best to promote the health of infants and mothers, and ended up getting hornswoggled by an evil pharmaceutical company.
As far as Barack H. Obama, Kathleen Sibelius, or Dr. Margaret Hamburg reversing their decision with the stroke of a pen, this is not the way it should work. Yes the decision should be reviewed and overturned to the extent that it is legally possible to do so, but not by the fiat of a political appointee. This was the sort of thing GW bush did to a large extent (nixing RU486 and many of the EPAs scientific statements). Doing so leads to science based on political opinion rather than fact. The people best able to affect on public health are those who have the experience and education to evaluate the proposal, and who have taken the time to study it. Not some gladhander who may have a medical degree but was primarily chosen for his administrative skills, and who could decide that vaccines cause autism because that’s what the polls say.
What is Dr. Zerhouni doing now, anyway?
http://www.cbsnews.com/8301-504763_162-20048870-10391704.html
It would seem that the FDA is declining to enforce the monopoly and allowing compounding pharmacies to continue to mix the drug.
They fear our wrath. Good. Internet, dumb metuant. KV Pharm was on the list. The list is long. Dirac Angestun Gesept!
It seems the FDA has done the public the same favor in regard to colchicine. They’ve been prescribing that one for about a gazillion years to treat acute gout flares. It used to cost 10 cents a pill. Now it’s $5. Here’s the FDA press release.
Makes me feel so protected and snug. How about y’all?
It has nothing to do with how old the drug is, and everything to do with the reason for administration. Listen, it’s not anybody’s problem but your own that you don’t know how drug patenting or the FDA works. Your basic understanding of patent law is shit as it relates to drug laws. So go educate yourself. No, it doesn’t apply to drugs, to say the least. Now go learn some shit or shut the fuck up about what you don’t know.
ETA: no, this use of the drug is not new. However, it is also not approved by the FDA. Off-label uses of a drug are not protected unless they are submitted with a new drug application for the amended indication of use.
It is available as a generic, in generic form of the medication that was originally approved by the FDA for the original usage. The new medication, which is indeed the old medication rebranded, will not have an AB equivalent generic on the market for about 7 years for that indicated usage.
I’m not sure what point your making here.
I’m glad this incident got some attention because pharmaceutical manufacturers have been pullling this crap for a long long time.
Back in the '70, there was a topical cream I used once for a skin condition-- Efudex. it is typical used as a topical treatment for skin cancer. In 1979 I paid less than $10 a tube for this stuff, no insurance.
Today, a tube of this ( checked on drugstore.com ) will set you back $350.00, $250.00 if you go for the generic. The same stuff I bought for under $10. I remember when the price surged, the manufacturer’s rationale was “it cures cancer, it should be expensive”.
The reason for the price gouging is simple as I see it. The doctor HAS to prescribe it and the insurance company HAS to pay for it to avoid getting sued. KV Pharma has NO incentive to do anything but price gouge. Not insured, screw you.
Since I started checking the actual price of the prescriptions I get filled I find this price gouging more often than not. I had an itchy ear and my doctor prescribed a little ear drop that was nothing but white vinegar and hydrocortisone in solution. The discounted cost that my insurer paid was over $200. Need Nasonex for allergies, be prepared to pay $150 if you aren’t insured.
I refuse to filll them, insurance or not…I go back to my doctor and demand something more price considerate or ( as in the case of the ear drop ) I whip up somethign myself or buy cheap bootlegs that claim to be from Canada but are really from India.
How does it benefit the citizens of this country to only approve off label uses of existing drugs in conjunction with granting a price gouging monopoly to the company making the application?