45 replies to this topic

[Cocomaan]

Disgusting.

Quote

Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.

Though KV Pharmaceuticals plans to offer financial assistance to low-come households in need of the drug, how private health insurance companies and Medicaid will respond to this price spike remains to be seen, leaving many doctors fearing that access to this treatment will become severely limited or interrupted for those currently mid-treatment.

And because FDA laws prohibit compounding pharmacies from making FDA-approved products, doctors will be legally obligated to stop using the cheaper version of this drug, a representative for the company told ABC News.

The best part? NIH did all the trials on it. That's right, your taxes were used for research and the private world is inheriting the profit. Public risk, private profit.

Quote

Many doctors are particularly frustrated with the price hike because to date, KV Pharmaceuticals has not had to bear the cost of the clinical trials used to get the drug approved, but they have announced plans to conduct further trials in the future.

"All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine.

Edited by Cocomaan, 15 March 2011 - 08:01 AM.

[Ser Lany Cassandra]

I had to be given this drug twice when prenant with my youngest son. I can just imagine the insurance company refusing to pay for this drug.

I guess I just don't understand why the government does things the way the do.

[TerraPrime]

Lany Cassandra, on 15 March 2011 - 08:35 AM, said:

I had to be given this drug twice when prenant with my youngest son. I can just imagine the insurance company refusing to pay for this drug.

I guess I just don't understand why the government does things the way the do.

My guess is that the FDA granted the exclusive right for the reason that the agency has evaluated the manufacturing spec and product of this company and trusts that it is of certified level of quality. The issue, from what I read, is that the drug has been made available by many different sources, none of which is monitored for quality per se. If say, one of the places that had been mixing up the drug got a contamination in it, I don't think the consumers will be very pleased. With certification comes quality monitoring that can be tracked. Also, the approval also makes the drug available through prescription in insurance plans.

I am guessing that the FDA was not expecting the company to jack the price to 1,500 per dose. They probably expect that the price would go up, but not to this range.

Of course, the FDA is not always clean in terms of the politics. I'd like to see who's on the approval panel, for instance.

I think it's easy to say "WTF, government, what you do that for?" when, imo, the true culprit is the drug company. The idea that we want a certified process of producing drugs that are used in child labor and to make this drug covered by insurance plans is a sound one, I'd argue. The excessive profiteering, on the other hand, is just symptomatic of the for-profit model of business.

Edited by TerraPrime, 15 March 2011 - 08:59 AM.

[Tormund Midgetsbane]

Government regulation is required in a free market. Otherwise unscrupulous business will compete and drive prices down.

[litechick]

TerraPrime, on 15 March 2011 - 08:58 AM, said:

My guess is that the FDA granted the exclusive right for the reason that the agency has evaluated the manufacturing spec and product of this company and trusts that it is of certified level of quality.

I don't understand. Aren't there several companies who have the capability to produce the drug with a 'certified level of quality'? Why does quality control have to equal exclusivity?

[TerraPrime]

litechick, on 15 March 2011 - 09:14 AM, said:

I don't understand. Aren't there several companies who have the capability to produce the drug with a 'certified level of quality'? Why does quality control have to equal exclusivity?

It could be a simple case of nobody else has bothered to apply for it yet? I don't know for sure. I'd have to find out more about this "exclusive right" thing from the FDA.

[Skunkbelly]

How common is it for doctors to prescribe progesterone to prevent PTL (pre-term labor) anyway? I've heard of it sometimes being used early in pregnancy to prevent miscarriage and sometimes later in pregnancy to prevent pre-term birth, but it doesn't seem to be all that widely used. (although perhaps now it will be since it's been FDA approved and would be covered by insurance.) Perhaps it's because it's a "preventative for" and not a "treatment of" PTL. I mean you, can be at risk for PTL and still not have early contractions. Is it that the drug company is setting the price so high that they are trying to recoup some of their costs in the research and production because not many women will be taking it?

eta: I still think it's not a nice thing to do to charge so much for the shots.

Edited by Lady Whitestripe, 15 March 2011 - 09:29 AM.

[Ser Lany Cassandra]

Lady Whitestripe, on 15 March 2011 - 09:27 AM, said:

How common is it for doctors to prescribe progesterone to prevent PTL (pre-term labor) anyway? I've heard of it sometimes being used early in pregnancy to prevent miscarriage and sometimes later in pregnancy to prevent pre-term birth, but it doesn't seem to be all that widely used. (although perhaps now it will be since it's been FDA approved and would be covered by insurance.) Perhaps it's because it's a "preventative for" and not a "treatment of" PTL. I mean you, can be at risk for PTL and still not have early contractions. Is it that the drug company is setting the price so high that they are trying to recoup some of their costs in the research and production because not many women will be taking it?

eta: I still think it's not a nice thing to do to charge so much for the shots.

Exept that they didn't do any of the research, the government did it. The drugs were already being produced and $10 was enough to cover them before their exclusive contract.

[TerraPrime]

I found some more information on the FDA site: http://www.fda.gov/D...e/ucm069962.htm

From what I can glean, the granting of exclusive right is routine for newly developed drugs. This protects the profit margin of this new drug and is intended to promote research and development from drug companies. At the same time, the exclusivity is limited to 5 years (or 3 years if it is a supplemental change), so that generic version of the drug can enter the market. To qualify for this 5-year exclusive right requires that the product "contain(s) chemical entities never previously approved by FDA either alone or in combination." So in this case, it would qualify since FDA has not (apparently) approved of the use of progesterone to treat pre-term labor before.

Far as I can see, the letter of the law has been followed, as far as the approval process goes. I question whether it followed the spirit of the law, which is to encourage innovation and development of new material. I wonder if there's enough to warrant a class action?

At any rate, I still think that the issue is not the approval, but the price gouging practice of the company. Though, it can be fairly argued, that the granting of the exclusivity enables this gouging practice. I do not think that this was the intent of the law, but it appears that it is one of the sad side effects.

[Ser Lany Cassandra]

TerraPrime, on 15 March 2011 - 09:46 AM, said:

At any rate, I still think that the issue is not the approval, but the price gouging practice of the company. Though, it can be fairly argued, that the granting of the exclusivity enables this gouging practice. I do not think that this was the intent of the law, but it appears that it is one of the sad side effects.

This is what I was thinking, that the exclusivity of the contract allows for the gouging, even though it is legal, I don't think it is what the law intended. Also, I always thought the exclusivity was so the company could recoup what they had already spent in R&D. In this case, the R&D was done by the government, so there was no losses to recoup.

[Tinydigit]

A Slate piece on the true costs of drug R&D: http://www.slate.com/id/2287227/

[Shryke]

Tormund Midgetsbane, on 15 March 2011 - 08:58 AM, said:

Government regulation is required in a free market. Otherwise unscrupulous business will compete and drive prices down.

Yup, cause the first thing we want drug companies doing is cutting corners to lower costs!

[Tormund Midgetsbane]

Quote

Yup, cause the first thing we want drug companies doing is cutting corners to lower costs!

I know right? That's why I only ever buy name brand ibuprofen. I'm certain that those generic brands are basically just sugar and rat poison in pill form. After all, cutting corners is the name of the game!

[Shryke]

Tormund Midgetsbane, on 15 March 2011 - 01:16 PM, said:

I know right? That's why I only ever buy name brand ibuprofen. I'm certain that those generic brands are basically just sugar and rat poison in pill form. After all, cutting corners is the name of the game!

Those generic brands are also regulated by the government.

[Tormund Midgetsbane]

Quote

Those generic brands are also regulated by the government.

Gee are ya sure? You're really stepping in here to defend the government granting a monopoly on a drug developed with government money?

[Shryke]

Tormund Midgetsbane, on 15 March 2011 - 01:42 PM, said:

Gee are ya sure? You're really stepping in here to defend the government granting a monopoly on a drug developed with government money?

No, that part is kinda stupid. Generic brands, however, are still subject to government regulation.

Though technically, it seems to function as simply a short-term patenting or the like. Which isn't a terrible idea theoretically. The main issue here is the company using that opportunity to jack the prices up by 150x for no reason beyond gouging the customer.

So in practical terms, it seems like a bad idea since the company can't be trusted to act even slightly in the public interest.

Edited by Shryke, 15 March 2011 - 01:59 PM.

[Swordfish]

Lany Cassandra, on 15 March 2011 - 10:02 AM, said:

This is what I was thinking, that the exclusivity of the contract allows for the gouging, even though it is legal, I don't think it is what the law intended. Also, I always thought the exclusivity was so the company could recoup what they had already spent in R&D. In this case, the R&D was done by the government, so there was no losses to recoup.

Why do you assume that there is gouging going on here?

Do you have some data to back this up?

There may, be, but I don't think that that is obvious.

There could, for example, be some regulation tied to the exclusivity that significantly impacts the cost of producing the drug.

Or, there could be some other factor at play.

[Chanur]

Lany Cassandra, on 15 March 2011 - 08:35 AM, said:

I guess I just don't understand why the government does things the way the do.

It is because there are a lot of kick backs and collusion between the FDA and big Pharma. Many high ranking employee's leave the FDA to end up working in a high paid position for one of the companies it approved a drug for. You should look into it, it is amazing that it is so blatant and allowed to continue.

Our terrible patent laws are why they can get away with this stuff.

Edited by Chanur, 15 March 2011 - 02:38 PM.

[Arlingzen Bill]

Chanur, on 15 March 2011 - 02:36 PM, said:

It is because there are a lot of kick backs and collusion between the FDA and big Pharma. Many high ranking employee's leave the FDA to end up working in a high paid position for one of the companies it approved a drug for. You should look into it, it is amazing that it is so blatant and allowed to continue.

Yes, it is amazing that the prescription drug plan doesn't allow for the negotiation of drug prices... You have the largest buyer of drugs saying it will accept the prices that pharma sets... grrrrr.

[Ser Lany Cassandra]

Swordfish, on 15 March 2011 - 02:19 PM, said:

Why do you assume that there is gouging going on here?

Do you have some data to back this up?

There may, be, but I don't think that that is obvious.

There could, for example, be some regulation tied to the exclusivity that significantly impacts the cost of producing the drug.

Or, there could be some other factor at play.

The original story where the EXACT same drugs were available for $10 and are now costing $1500. That is the data backing up my gouging comment.