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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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March 11, 2011

Makena's Price: What to Do?

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Posted by Derek

The situation with KV Pharmaceuticals and the premature birth therapy Makena has been all over the news in the last couple of days. Briefly, Makena is an injectable progesterone formulation, given to women at risk of delivering prematurely. It went off the market in the early 1990s, because of side effect concerns and worries about overall efficacy, but since 2003 it's made an off-label comeback, thanks largely to a study at Wake Forest. This seemed to tip the risk/benefit ratio over to the favorable side.

Comes now the FDA and the provisions for orphan drugs. There is an official program offering market exclusivity to companies that are willing to take up such non-approved therapies and give them the full clinical and regulatory treatment. The idea, which is well-intentioned, as so many ideas are, was to bring these things in from the cold and give them more medical, scientific, and legal standing as things that had been through the whole review process. And that's what KV did. But this system says nothing about what the price of the drug will be during the years of exclusivity, in the same way that the approval process for new drugs says nothing about what their price will be when they come to market.

KV has decided that the price will now be about $1500 per patient, as opposed to about $15 before under the off-label regime. The reaction has been exactly what one would expect, and why not? Here, then are some thoughts:

Unfortunately, this should not have come as a surprise. It seems to have, though. The news stories are full of quotes from patients, doctors, and insurance companies saying that they never saw this coming. Look, though, at what happened recently with colchicine. Same situation. Same price jump. Same outrage, understandably. As long as these same incentives exist, any no-name generic company that comes along to adopt an old therapy and bring it into the modern regulatory regime can be assumed to be planning to run the price up to what they think the market will bear. That's why they're going to the trouble.

KV seems to have guessed correctly about the price. You wouldn't think so, with a hundred-fold increase. And the news stories, as I say, are full of (understandably) angry quotes from people at the insurance companies who will now be asked to pay. But (as that NPR link in the first paragraph says), Aetna, outraged or not, is going to pony up. It's going to cost them $20 to $30 million per year, most of which is going to go directly to KV's bottom line, but they're going to pay. And the other big health insurance providers seem to be doing the same. Meanwhile, the company has announced a program to provide low-cost treatment to people without insurance. From what I can see, it looks like basically everyone who had access to the drug before will have it now, the main difference being that the payers with deeper pockets will now be getting hammered on by KV. This is not a nice way to run a business, and it's not something I would sleep well on after having done myself. But there it is.

How much is regulatory approval worth, anyway? That seems to be what we're really arguing about. After all, patients are getting the same drug, in the same formulation, dosed the same way as before. But now it's **FDA Approved**. For new substances, I think regulatory approval is worth quite a bit. There are all kinds of things that can go wrong. But how about drugs that have been dosed in humans for years? And already run through the equivalent of Phase II trials by other people? The main thing that's being added is some confirmation that yes, the dose that everyone's been using is about right, and yes, the effects that are being seen are, in fact, real. And that's not worthless, not at all - but how much is it worth, really? The agency itself seems to place a pretty high value on it - seven years of market exclusivity, to be exact, and we can see by example just what that goes for on the market.

This does the drug industry no good, either. We have a bad enough reputation as it is, wouldn't you think? What's irritating, to someone like me who works at a "find a new drug" type of company, is that these no-name generic outfits (KV in this case, URL Pharma for colchicine) are doing pretty much what critics of the industry think that we all do, all the time. That is, walk up to situations where other people have done a lot of the work, a good amount of it with public/NIH money, and step right in and profit. Now it's true that these companies have to basically run Phase II/Phase III trials to take the data to the FDA, and that's a significant amount of money. But their risks in doing so have been watered down immensely by the history of these drugs in the medical community. When a research company closes its eyes, holds its breath, and jumps into the clinic with a new molecule, that's one thing. And that's where those 90% failure rates come from. But the failure rate of drugs that have been used for years in human patients already, and already studied under clinical conditions, is not anything like 90%. Is it zero per cent? Has anyone failed yet, taking one of these old medications back to the FDA? Even once?

The company picked its target carefully. I will say this, that KV's trials have presumably clarified the question of whether progesterone therapy actually does help. You'd think that the 2003 study would have answered that, and as it turned out, it had. A review of the field in 2006 concluded that it was a worthwhile therapy, from a cost/benefit standpoint, as did another review in 2007. (Mind you, that wasn't at any $1500 a throw, was it?) But a Cochrane review from last year concluded that there still wasn't enough evidence to recommend the whole idea. And progesterone therapy doesn't seem to help with twin or tripletpregnancies or with some other gestational problems. No, the 2003 study seemed fairly strong, and has the greatest relevance to public health, so that's what the company went for. From one viewing angle, the system worked.

My take, though, is that as long as the regulatory environment is set to value FDA's stamp of approval for old drugs this highly, that people will continue to take advantage of it. You subsidize something; you're going to get it. Personally, I don't think that the balance is right, but I'm open to suggestion about what to do about it. A shorter period of market exclusivity would just mean, I think, that the prices go up even higher once a drug gets re-approved. Just throwing up our hands and letting all that old stuff stand is a possibility, but there may well still be some of these things that aren't as effective as we think, or aren't being dosed right, and we have to decide what the cost is of letting those situations stand.

Update: see also Alex Tabarrok's thoughts on the effects of the Orphan Drug Act in general.

Comments (57) + TrackBacks (0) | Category: Clinical Trials | Drug Development | Drug Prices | Regulatory Affairs | Why Everyone Loves Us


COMMENTS

1. Anonymous on March 11, 2011 9:13 AM writes...

One correction: Makena is 17-hydroxyprogesterone caproate, not progesterone.

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2. John Thacker on March 11, 2011 9:34 AM writes...

Just throwing up our hands and letting all that old stuff stand is a possibility, but there may well still be some of these things that aren't as effective as we think, or aren't being dosed right, and we have to decide what the cost is of letting those situations stand.

Having the FDA regulate efficacy in general isn't worth it. The FDA should go back to the pre-1962 situation of regulating for safety only. The current policy not only costs more, it demonstrably kills far, far more people than it saves.

The scientific evidence is nearly indisputable. The current scheme makes it easier to sell snake oil without any claim than to sell something on the basis of scientifically rigorous claims. Indeed, making any reference to a scientifically rigorous study will get the FDA on you, whereas fluffy misleading meaningless claims are perfectly fine.

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3. John Thacker on March 11, 2011 9:36 AM writes...

Having the FDA regulate efficacy in general isn't worth it. The FDA should go back to the pre-1962 situation of regulating for safety only. The current policy not only costs more, it demonstrably costs the lives of far, far more people than it saves.

The scientific evidence is extraordinarily strong. The current scheme makes it easier to sell snake oil without any claim than to sell something on the basis of scientifically rigorous claims. Indeed, making any reference to a scientifically rigorous study will get the FDA on you, whereas fluffy misleading meaningless claims are perfectly fine.

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4. Kay on March 11, 2011 9:53 AM writes...

FDA approval isn't just for efficacy. It also means the manufacturing process is being regulated - that the drug is being manufactured under proper GMP, that their raw materials are good quality, etc. There's very little oversight of compounded drugs as far as manufacturing.

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5. NoDrugsNoJobs on March 11, 2011 10:07 AM writes...

Good points Derek - there still clearly is some risk and costs towards this sort of "research" but it is much less than one takes with a brand new therapy. You are also right that if the exclusivity period is shortened, that prices will go up even more since their is less time to profit from the drug. Yet the rule has its value because we need to investigate the use of drugs that have never been approved because we all know that absent the correct types of trials we could be really deceiving ourselves as to how or whether something might be working. The pricing does further diminish our industry reputation (if that is possible) while the one's to shoulder the blame (name brand pharma) are not the one's culpable. Maybe this would be a good area for the NIH's new drug discovery division to tackle - they could focus on bringing non-approved drugs in wide use to market and then the government could sell the drug for a more reasonable price. This way, they could provide a service while at the same time not try to get into the real drug discovery business. Since the government funds many clinical studies of non-propietary therapies, this would be a logical next step for them.

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6. Hap on March 11, 2011 10:30 AM writes...

The government doesn't even have to sell them - if they're simple enough, generics manufacturers could make them, and if there's actually a benefit, they'll sell more of them. Of course, if there's not, they won't (hence there's risk to them).

I had hoped, though, that those kinds of trials would be what the alternative medicine office would be doing, but I'm guessing not.

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7. SteveH on March 11, 2011 10:46 AM writes...

What's the problem? The firm took a drug, in which no other company was willing to invest money (multiple manufacturers had already discontinued production of this drug), and performed the expensive clinical trial work to scientifically support the efficacy claim. I don't see how this is any different than the marketing exclusivity that the innovator companies claim is essential to recoup their R&D investments. You can't clamor for a free market, then cry when the market prices a product higher than you like. Maybe Hologic is taking advantage of the exclusivity rule, but everyone in the drug business knows the rules. Every other NDA holder is fiercely protective of THEIR drug product's exclusivity rights, and not one of these companies welcomes competition.

Innovator drug firms (see "How much is regulatory approval worth, anyway?" above) also play this game - new efficacy supplements serve to extend exclusivity and fend off generic competition. They clearly know that FDA approval is worth something.

Sorry, John Thacker, your idea would lead directly to an open market of "snake oil", driven by unsupported claims, internet astroturfing and desperate patients. FDA's enforcement initiative to block marketing of unapproved drugs is clearly inent on getting "snake oil" drugs off the market.

And Kay, you are excatly right. This is all part of the anti-snake oil intent of FDA.

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8. NoDrugsNoJobs on March 11, 2011 10:59 AM writes...

Steve H - your point is taken but I think you might be missing some of the subtle differences and the effects those have on people. When pharmaa brings a new drug to the market, they are not removing an old drug that is identical to the new drug and then selling the old drug at 100 times the cost. The pateints of pharmas new drug simply have the option of taking a new therapy but the old therapy is not being forcibly being taken away from them. In this instant, the therapy is already there and they are using it for 15 bucks or whatever. Now, that option has been removed from them - they cannot take the old 15 dollar shot but now have to take the new 1,500 dollar shot which sounds like the exact same shot. I agree that the company has done something valuable and have played by the rules and are not doing anything illegal but is it something that is good for the industry?

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9. Cloud on March 11, 2011 11:24 AM writes...

I suspect that even at the higher price, the drug will turn out to be a good deal for insurance companies, due to the even higher price of complications from premature birth. In fact, I suspect some actuaries at the big insurance companies have crunched the numbers and could tell us the details.

But that doesn't mean I like the situation.

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10. processchemist on March 11, 2011 11:27 AM writes...

"FDA approval isn't just for efficacy. It also means the manufacturing process is being regulated - that the drug is being manufactured under proper GMP, that their raw materials are good quality, etc. There's very little oversight of compounded drugs as far as manufacturing."

Let's get serious. GMP in the generics arena, where most of the APIs are manufactured in Chindia, is just a word and some papers. Certifications are a matter of *controls*, and if you're unable to control all the manufacturers with ingredients allowed in your nation any claim about quality bioequivancy safety sounds empty if not sloppy. The compounding company in USA or Europe is easy and cheap to be controlled, the 16-hydroxyprogesterone manufacturer somewhere in the Sichuan has the lowest probability you can think of to get an FDA inspection.

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11. John Wayne on March 11, 2011 11:29 AM writes...

Here's how I see this: this compound had a history of use to prevent premature birth, but the FDA had a doubt if the therapy was efficacious. At this point they had a choice: have the government pay to run the study, incent somebody in the private market to do it for them, or do nothing. They went with option B, and the endgame provided Makena 7 years of excusivity.

Now Makena has made an investment, and the money and they put forward paid off. At that point the question is not, 'how much did this cost before.' They question is, 'how much is the proven therapy to prevent premature birth worth?' They came up with a price of $1500.

If my wife was at this risk, my insurance company and I would happily pay an extra $1485 for a therapy with the best clinical backup. They even have a program for people who have finiancial need, and we'll only have to pay this extra money for 7 years.

That is the price of data. Do people want to take unproven medications? Oh, er ... that stuff makes billions a year and is advertised on TV. Is this outcome better or worse than the other two options presented at the outset? Can a government agency do these clinical trials? Should we have done nothing? It seems unfair, but this is better than the alternatives.

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12. TJM on March 11, 2011 12:28 PM writes...

I agree that the perceived increase in cost of the therapy will further worsen (if possible) regard for the industry. But to be for clarification:

- Is the "new" product a synthetic offshoot of the old therapy? If so costs are higher, but the specific benefits are now proven for a well-controlled active ingredient, with AE's (perhaps) reduced from past pharmacy mixes. Variations in natural sources can have related components (even in base molecule folding) that might have been causing reactions. See previous discussions of hormones derived from mare urine in the past to see the breadth of this kind of risk. These variants and their potential adverse effects would not have been understood as being caused by the former therapy as there were not well controlled clinical trial guidelines or controls.

- If there is greater control on such variations and lower AE's, is this not value-added? To determine, one might do a meta-analysis if the health records of past pregnancies could be evaluated. Few really like retrospective meta-analyses, but this may become more and more refined and accepted, with the advent of EHR’s and NICE-like entities. However the point is that society’s valuation of improved outcomes in pregnancy is very high, considering consequences and costs of premature births and their resulting conditions.

- Does running trials on such a delicate area as pregnancy involve more risk than validating something like a therapy for migraine? Pharma has been loath to do trials on certain patient populations because of these societal sensitivities, and the heightened risk for liability. What is this risk worth?

The above are not intended to justify the pricing, but to ask the audience for clarification on those aspects. Are the above valid dimensions of risks and costs that the next firm considering orphan drugs, needs to consider and endure?

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13. Jeffrey Soreff on March 11, 2011 12:40 PM writes...

"Can a government agency do these clinical trials?" certainly sounds like another possible option. One way or another, if the patient population is going to get the improved information from phase II/III trials, it has to be paid for somehow. I'm not sure whether the price increase in a generic product is the right choice: Running the trials was costly, but adds no _incremental_ cost to the drugs, so increasing the drug price isn't sending the right economic signals to patients (or insurers). Ideally the pool of prospective patients should make a cost/benefit decision on running the trials but I doubt that that could be done. A lump sum payment by we taxpayers to run the trials seems (with no subsequent change in the generic status) seems about as good a choice as any.

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14. Better Childbirth on March 11, 2011 1:10 PM writes...

Instead of overpriced and synthetic (thus not to be trusted) drugs, pregnant women concerned about a possible premature delivery should be advised to use a bio-identical progesterone cream, much less expensive and perfectly safe.

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15. SteveH on March 11, 2011 1:10 PM writes...

@NoDrugsNoJobs - No, I am not unaware of the effects that economic thought has on patients. I deplore it, but it is an essential component of an industry that remains a for-profit industry.

I am not naive, but I am idealistic in a lot of ways. I think that the pharma and health insurance indstries are locked in a symbiotic relationship that may destroy them both. Drug firms feel they can price their product without regard for the affordability to to patient, since the insurance company will be the ultimate payer, and the insurance companies raise rates and deny claims to boost their bottom lines. This is, in the long run, unsustainable.

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16. Better Childbirth on March 11, 2011 1:11 PM writes...

Instead of overpriced and synthetic (thus not to be trusted) drugs, pregnant women concerned about a possible premature delivery should be advised to use a bio-identical progesterone cream, much less expensive and perfectly safe.

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17. Various Positions on March 11, 2011 1:21 PM writes...

100 fold markup seems more like rent seeking than fair compensation for running a trial. Maybe instead of market exclusivity companies who get approval for orphaned drugs should get X% of their competitors revenues for, say, 10 years. (On the one drug in question of course). So they get exclusivity if they set their price low enough, or some extra revenue if they do not.

Just my initial reaction. No time to think about it more as I have to get back to discovering drug that have decidedly not already been on the market for years.

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18. SteveH on March 11, 2011 1:41 PM writes...

@Jeffery Soreff and John Wayne - In these divise, anti-government times, no one can expect the government to be able to conduct clinical trials for a new or old drug. If it tried, the cry would go up that they are trying to nationalize healthcare research. If they tried to pass a levy (as some other countries do to pay for extraordinary expenses, such as NZ for rebuilding Christchurch, or AUS for the flood damage), the "Don't tax me" crowd would go berserk.

Plus, orphan indications are very, very difficult to do trials for. The patient population is small, scattered across the country (making conduct and coordination difficult and expensive), and they don't neccessarily want to take the chance on getting a placebo.

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19. wearinbeads on March 11, 2011 2:29 PM writes...

It is indeed a wonder there are any orphan drugs approved.

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20. wwjd on March 11, 2011 2:47 PM writes...

The government should provide a prize for running a study on a drug like this instead of providing market exclusivity. In order to entice the studies to be run, the prize needs to cover expenses plus some profit. So say 43 mil + an extra 8.6 mil for the trouble?

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21. John Wayne on March 11, 2011 3:16 PM writes...

It seems like doing these sorts of clinical trials by incenting private companies is the way to go. We don't trust the government to do it (right or wrong), and doing nothing seems like a poor choice.

Nobody can deny that there is this feeling of being tricked; after all, the same injection costs 100x more money now. On the other hand if a doctor comes at my pregnant wife with a syringe full of hormone, I'd like to know that it is both efficacious and safe for her and the baby.

We could get into a discussion about the maximum financial benefit of such a study could provide a company. It is really an interesting question of how to get the most bang for our healthcare dollar, because the financials any system you put forth will determine pretty much entirely which orphan or historical diseases/drugs get studied. I don't have any brilliant answers, but the problem is kind of beautiful in it's complexity.

Did anybody else look at the post from Better Childbirth and think, "it's a trap!"? Most of us who read Derek's blog didn't get to be such big fish by going for the first bait that comes along, but thanks for giving us all a chuckle.

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22. Bruce Hamilton on March 11, 2011 3:17 PM writes...

The clinical trial that facilitated FDA approval apparently involved 463 susceptible pregnant women, and showed an 18% improvement. That trial size doesn't seem like sufficient expense to justify exclusivity.

It seems the " hundreds of millions of dollars in additional research" has yet to be conducted, and presumably will be funded from the new price.

Perhaps exclusivity should proportional to the new knowledge added to existing knowledge, not just by providing only an appetizer, with promise of more courses after enough people have paid for their meals.

It seems KV have found a successful business model, but it has a very bad aftertaste. The responsibility for this mess is the FDA, and they should fix the problem.

Permalink to Comment

23. John Wayne on March 11, 2011 3:19 PM writes...

It seems like doing these sorts of clinical trials by incenting private companies is the way to go. We don't trust the government to do it (right or wrong), and doing nothing seems like a poor choice.

Nobody can deny that there is this feeling of being tricked; after all, the same injection costs 100x more money now. On the other hand if a doctor comes at my pregnant wife with a syringe full of hormone, I'd like to know that it is both efficacious and safe for her and the baby.

We could get into a discussion about the maximum financial benefit of such a study could provide a company. It is really an interesting question of how to get the most bang for our healthcare dollar, because the financials any system you put forth will determine pretty much entirely which orphan or historical diseases/drugs get studied. I don't have any brilliant answers, but the problem is kind of beautiful in it's complexity.

Did anybody else look at the post from Better Childbirth and think, "it's a trap!"? Most of us who read Derek's blog didn't get to be such big fish by going for the first bait that comes along, but thanks for giving us all a chuckle.

Permalink to Comment

24. BigSky on March 11, 2011 3:22 PM writes...

No, this is indefensible behavior by both the FDA and KV. The previous method was akin to a bartender dispensing beers from a keg only to have a company patent the 13.25 oz. beer, charge 120$ and send cease-and-desist letters to bartenders.

KV Pharma is now and has ever been unethical and criminal players in the industry. Even given this latest example, the sad fact is that they have paid such a small penalty for their actions.

As one Wall Street observer noted... A year in ash-pounding prison and personal (as opposed to shareholder) fines would put a stop to this.
http://www.stltoday.com/business/local/article_693616ab-1af6-5d34-a763-6fd01683aa5c.html

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25. Bruce Hamilton on March 11, 2011 3:27 PM writes...

SteveH at 18. Sorry to digress...

It's not clear that an additional national levy will be imposed by the New Zealand Government to pay for rebuilding Christchurch. Options are still being considered, and the PM isn't enthusiastic about imposing one. He may have to, but still is exploring all options.

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26. GreedyCynicalSelfInterested on March 11, 2011 3:51 PM writes...

A day in the ICU costs more than $1500. The company needs to charge more to pay for all the lawsuits. You have to feed the ambulance chasers one way or another.

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27. partial agonist on March 11, 2011 4:01 PM writes...

BigSky said: "The previous method was akin to a bartender dispensing beers from a keg only to have a company patent the 13.25 oz. beer, charge 120$ and send cease-and-desist letters to bartenders"

No,

the previous method was akin to a bartender giving out an unknown liquid, telling you that he was completely unsure what it would do to you, that he had no reason to suspect that it was safe or not, and that in fact it had once been pulled from the market, but it was very cheap

vs. the bartender dispensing beers with the full Guiness label, straight from the factory, and properly chilled, with some nuts on the side.

I pick "B" at any price, if I pick anything. If the matter is life and death vs. getting a nice drink, I certainly do choose B and am thankful for having the choice.

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28. CMCguy on March 11, 2011 4:20 PM writes...

Granted the story appears here as poor reflection on KV and Industry however there are many questions that need to be answered to sort this out to understand:
To be used "off-label" it would be necessary to have approval for something so does anyone know what that was/is? If no approved uses then MDs would not have access expect for illegitimate sources.

At $15/dose typically need a big indication/quantities as driver since small annual demand meaning the manufacturing expenses on per unit basis remain high and significant (although Raw Materials look to be very cheap in this case).

As an orphan indication the approved target population is small so how many pregnancies might need this drug? This drug did have a head start that if was starting from nearer ground zero probably would not have been pursued (except by government?).

Further what is the potential (probable) Liability with a drug like this as expect lawyers would pounce on any circumstance they could to sue (so thats $1000/dose there just for in-house lawyers/insurance right?)

Assuming no additional Patent coverage possible 7 years is not that long to get a positive ROI before generics can come in (and those likely will not be at $15 price point either).

Although do not agree fully with customary concept as pointed out this price reflects what "market will tolerate". This often has little to do with what it actually costs to make, and frequently indirectly what particular R&D costs and one hopes KV takes those profits and uses them to discover and develop new products but as a Generic company would be a rare re-investment.

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29. NoDrugsNoJobs on March 11, 2011 5:07 PM writes...

Good point about covering the legal liabilities - that is something that has kept most drug companies away from treating pregnant women. Its a shame but the tort liability system in the US is the laughingstock of the whole world.....

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30. Melissa-mom of a preemie on March 11, 2011 7:40 PM writes...

I didn't see a mention of this anywhere in the article OR in the comments, but this medication is often used up to 20 weeks of a pregnancy. So we aren't talking about $15 versus $1,500 (which is still ridiculous), but $300 versus $30,000!

And even then, 17P is not a guarantee that a baby won't come early and require a NICU stay...it IS a chance to take a pregnancy past the danger zone of 24-30 weeks.

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31. not bob on March 11, 2011 9:03 PM writes...

"A shorter period of market exclusivity would just mean, I think, that the prices go up even higher once a drug gets re-approved."

I disagree. I don't think the $1500 price point arose from any calculation of development costs. I think they analyzed the market, identified the point at which maximum profit could be extracted (i.e volume*unit margin) and priced the product accordingly.

Whether they have one year of exclusivity or one hundred doesn't change that pricing calculus.

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32. cynical1 on March 12, 2011 2:07 AM writes...

@#30 Melissa

Well stated.

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33. Carly on March 12, 2011 9:08 AM writes...

Emphasizing Melissa's comment.. treatment for 1 full term pregnancy is now $30,000 yesterday it was $300. The $1500 cost is per DOSE, a woman needs 20 doses

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34. Rick on March 12, 2011 10:03 AM writes...

I'm also surprised by the magnitude of the price increase, regardless of the duration over which it would be paid. However, whether we like it or not, this is market economics behaving as it is intended. "The market" has spoken. Presumably, consumers will reply and Adam Smith's invisible hand will move accordingly. There will be collateral damage along the way, but that's the price we pay for freedom (of the market).

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35. SteveSC on March 12, 2011 8:01 PM writes...

For those above who feel comforted by the quality implied by FDA approval, check out KV's 10-Q on pages 9 and 10. Apparently they decided to ship morphine tablets that had 65% more active than labeled. Their CEO just pled guilty and is going to jail. Of course KV 'cleaned up' their act by shutting down the subsidiary that had the problems and moving assets to a 'new' subsidiary.

Given this history, I would personally feel better about getting it made by my local compounder, who I can look right in the eye.

IMHO, this and the removal from the market of grandfathered drugs is just a combination of power grabbing by the FDA with crony capitalism.

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36. Jeffrey Soreff on March 13, 2011 12:12 AM writes...

@34 Rick - In non-monopoly situations, competition puts a lid on prices. Patents and exclusivity awards are _not_ the free market at work. None of the microeconomic theorems about the efficiency of perfect competitive markets apply here.

That said, there obviously has to be an incentive to discover new treatments, and new data (positive or negative) about old treatments. Whether a temporary government monopoly in the best choice is by no means clear. It certainly isn't the only possible model: prizes are another, lump-sum payment by the taxpayers is another, sampled licensing fees (as is done for some background music) is a third.

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37. Ri