Doxycycline is another old-timey drug that has skyrocketed in price. At one time doxycycline cost less per capsule than empty capsules sold for compounding. Then, tick borne diseases like borreliosis (Lyme) emerged, which is treated with doxycycline. Now there are high prices and shortages.
Doxycycline and minocycline are also very important for the treatment of community-acquired methicillin resistant staph aureus (CA-MRSA). The tetracyclines and sulfa drugs are still the best way to treat this rampant organism.
This is an unintended consequence in the changing how foreign drug manufacturers are inspected.
My understanding is that there was a recent change in the regulations regarding overseas manufacture of generic drugs. Manufacturers now have to pay for inspectors for each generic drug they want to manufacture. This means most manufacturers only pay for drugs they are currently producing. Many low demand drugs have effectively only one producer and now that producer has a legal monopoly. Because whereas before any attempt at driving up the prices invited new generic manufacturers now only those who have paid for an inspection can manufacture the drug. Thus a new barrier to entry has caused prices to go up.
To answer the OP’s question directly, because in the US, pharmaceutical companies can charge whatever they like.
Well, maybe so, but it’s definitely still prescribed in the UK, because I’m on it to treat Schoegren’s Syndrome and, separately, my GP suggested it to treat my folliculitis before realising I was already on it. Schoegren’s is not that common, but folliculitis is. Just picked up a prescription for it about an hour ago. So that’s one Western country where it’s not rarely prescribed, and is very, very cheap (to the NHS, that is. Free for me).
My Schoegren’s doctor even said “doesn’t matter what sort of tetracycline,” IOW it doesn’t matter what non-generic name it’s being sold under - which means it’s made by multiple pharmaceutical companies. That usually helps keep the price of a drug down.
I don’t think possible rarity in the US explains the price there, because it’s not like drugs are all made in-country.
It’s an important drug in the US—it’s just not prescribed all that often.
The fact that it’s rarely prescribed doesn’t justify its high cost—rather, its cost is what the US market will bear. I’m not saying that’s the “right” price for it, of course. I think we all agree that the cost of tetracycline in the US bears little relation to the cost to produce it.
My post was in response to a suggestion that tetracycline isn’t prescribed often in the US. I had missed Nava’s post explaining why that is, so when someone else suggested the same, I objected that it is an important drug and therefore likely prescribed frequently—and I was wrong about that. I thought I should acknowledge my error.
None of that means that you don’t have a tetracycline prescription or that an American with Shoegren’s Syndrome wouldn’t get (and easily fill) a prescription for tetracycline.
This ties I to what I was thinking of, how when there is low demand you have a de facto monopoly since domestic and international competition are either banned or not worth the effort.
That article implied they were trying to work on it, but it also mentioned President Obama do in assuming it is very out of date.
Is anything being done to make it easier for new companies to being generics to marketplace when the single supplier jacks up the price?
I briefly thought I had this figured out. Hmm - maybe, maybe not.
I think this thread has been a pretty good analysis - supply and demand is the obvious thing to look at; so I thought I’d take a look at supply.
The FDA provides a list of approved drug products. If you search by drug name (letter T, obviously) you can find Tetracycline Hydrochloride under letter T on page 2.
Click on that and it will open up, listing all Tetracycline approvals. One of the items of information is the marketing status. Of the ~30 entries, all except 4 are discontinued. Those not discontinued:
Watson (1st entry) approved 1974
Chartwell Tetra approved 1988 with some regulatory activity (labelling*) in 2016
Breckenridge approved 11/2018
Amneal approved 9/2018
So if I had to speculate about the history events here, I might guess that there was at one time only one active licence. Supply and demand issue leads to price escalation. Subsequently, one other supplier with a licence brings their licence up to date so that they can market; and two new suppliers make applications which are approved last year. Just a guess, of course.
Now, add to that some information from the link that puddleglum found - median approval time for a new generic = 31 months. This means that if I spotted a price rise and did a quick deal with (say) a company with a licence in Canada for the US rights to their product, then put together a US application using all the Canadian company’s data - it might still be about three years before I could be in the game. (Made up example obviously - I’m just trying to illustrate the timeline).
What I don’t understand is this: there appear to be 4 companies active in the US market. If there was a point when there was only one, then yes I see at that point the price might be very high - but if the industry has reacted and there are now 4, why is the price still so high?
j
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- note that labelling is not a trivial matter. This could, for example, mean the addition of more safety data, without which the product could not be marketed.
Your analysis, and this whole thread, are really interesting to me.
I don’t know whether your analysis that there are currently four approved competitors for this drug is correct but, even if it is, the price wouldn’t necessarily drop immediately. The competitors got into the business because the price was very high and would be profitable for them. All of these competitors benefit if the price remains high so the new competitors may be attempting to compete on some basis other than lower prices, such as faster shipping, lower order quantities, or better-looking sales people. It could take some time before one of the new entrants decides that the best way to profit off the investment in its FDA approval is by starting a price war.
At the very least though, multiple competitors are likely to keep any of the competitors from jacking the price up any further.
Just as an aside, tetracycline for animal veterinary use seems to have been in short supply this summer. Don’t know if human/animal antibiotics would be coming off the same line, just with differences largely in regulations. All the veterinary tetracycline I’ve seen has come from the UK, so maybe if it’s commonly prescribed for human use over there than that’s where most of it is made in any form, and there’s some logistical issue in getting it to the US? Hard to see what it would be, though.