Pregnancy drug's sharp price hike called 'greed'

[Divernan]

Source: Pittsburgh Post-Gazette

The FDA recently gave a drug company exclusive rights to produce the drug, dramatically raising the cost. The revelation this week that the cost of a popular drug to help prevent preterm labor is going to go up 100 times its current price has stunned pregnant women, their doctors and pharmacists in Western Pennsylvania.

Typical doses of 17P that now cost $10 to $20 per dose will have a list price of $1,500 under the brand name Makena. That's because KV Pharmaceutical of suburban St. Louis last month won government approval to exclusively market and sell Makena, a synthetic version of the hormone progesterone.

What bothers doctors, pharmacists and patients about the cost is that Makena is merely a rebranded version of a drug that had been in use for 50 years but had gone out of use 11 years ago, earning the "orphan" drug status.

Before it became an orphan drug, it was used for disorders of the adrenal glands or the ovaries. But it found a new use after a 2003 National Institutes of Health-funded study found that only 36 percent of women at risk of preterm labor who were given 17P had premature birth, compared with 55 percent of women who were not given the drug.



Read more: http://www.post-gazette.com/pg/11070/1131217-84.stm#ixzz1GI4X5R00


Read more: http://www.post-gazette.com/pg/11070/1131217-84.stm

---

Here we have Obama's FDA, in bed yet again with Big Pharma.

This was a GENERIC drug, in use for over 50 years. It was so inexpensive and had so little demand that no Big Pharma companies chose to produce it, so 11 years ago it went out of commercial production and became what is known as an "orphan drug". Then a 2003 National Institutes of Health funded study reported that the drug significantly reduced the risk (from 55% to36%) of early labor. Since then, special pharmacies which custom prepare meds have been selling individual doses for individual patients - at $10 to $20 per dose.

OBAMA'S FDA HAS NOW GIVEN ONE COMPANY EXCLUSIVE MANUFACTURING RIGHTS AND IT WILL SELL EACH DOSE OF A GENERIC DRUG FOR $1,500. Insurance companies report they will take months to decide if this is covered. If it IS covered, whether by Big Health Insurance or Medicaid, the costs will be spread out to all us insureds and taxpayers. Women should have continued inexpensive access to this drug. The drug company's profits of $1,490 per dose for a drug they didn't even have to develop, are beyond obscene. Way to go, big O!

Cue the Obama loyalists - tell us all where this fits into his grand multi-dimensional chess game.

[ejpoeta]

1. how can they get away with this!! i have assumed the FDA was in the pockets

of those they were supposed to be regulated but this is so blatant!! wtf!

[Divernan]

2. The FDA is Obama's creature - under the administrative branch of govt.

The buck stops with him - and the Big Pharma bucks go TO him, re campaign contributions.

I have never asked for rec.s before, but would like to see 5 to keep this on the greatest page for the morning.
Thanks.

[Turborama]

12. I just rec'd it up to 18

Is this the same drug? http://en.wikipedia.org/wiki/Allylestrenol

If so, please see my post below.

[customerserviceguy]

3. What authority would the FDA have over foreign manufacturers

who would make this drug in their plants? The only thing I could think of was that the FDA would officially ban importation, but we see how well that works with Canadian pharmacies. The drug would just be sold and distributed on an underground market.

That said, I'd like the hear the President's explanation on this one.

[theaocp]

16. Hahahahaha!

You think he's going to take the time out of his day to explain this? Please. He. does. not. care.

[Divernan]

18. He DOES SO care! - about keeping Big Pharma happy!

If he and his FDA get by with this for THIS generic drug, think of the billions to be made by Big Pharma with all the other generic drugs! And the quid pro quo is that they will continue to fill Obama's campaign coffers! My god, how the money rolls in!

[sgsmith]

19. By law.

The FDA has total authority dealing with medicines sold in the US, regardless where in the world they're manufactured. This includes inspection authority at the foreign manufacturer's plant.

It's been that way for the entire existence of the FDA, I think.

[timtom]

4. Clearly a black market for this will arise

thus feeding once again into the "criminal" "justice" system.

[Divernan]

10. Black market drugs are not quality controlled - too dangerous for pregnant women

[AlabamaLibrul]

21. Imported drugs are not quality controlled by the FDA.

It's made in the same labs by the same chemists.

Of course, that would be illegal, importing drugs to ensure you don't have a premature baby.

[Lyric]

26. I think you're forgetting that pharmacies have been compounding this stuff for years.

At worst, the "danger" would be no higher than it was BEFORE the FDA granted exclusive rights.

[Divernan]

28. I have observed that there are counterfeit drugs offered on line.

In that this drug is marketed as an injection of a liquid, it would be so simple to offer a fake drug. Local, compounding pharmacists are licensed. Black market/purchased on line could be mixed/made/compounded by anyone of anything.

[gkhouston]

29. That's why you'd use a reputable compounding pharmacy, preferably one

that's P.C.A.B. accredited. Some of them do mail order.

[brer cat]

5. Where are the pro-lifers on this one? K&R

[Divernan]

6. Drug company's stock surges 31%; subsidiary pled guilty to criminal charges

Anticipates sales of $420 million by end of 2013.

http://www.stltoday.com/business/local/article_e1693454-70b6-5387-a552-08c89bb4b149.html

Shares of KV Pharmaceutical Co. surged 31 percent Tuesday after the Bridgeton-based drugmaker announced its launch date next week for a prenatal drug.

In a Securities and Exchange Commission filing, company officials said that by the end of 2013 its net sales from Makena could reach about $420 million — or about 90 percent of the company's net revenue.

For years, doctors have prescribed the same drug on an "off-label" basis under the label 17P, which is sold by chemical compounding pharmacies.

KV, whose wholly owned subsidiary, Ethex Corp., pleaded guilty to criminal charges last year for shipping oversized morphine tablets, plans to raise fresh capital to meet its obligations.

[Divernan]

8. Subsidiary history - massive recalls, non-compliant manufacturing conditions

Obama's FDA should be tightly monitoring this subsidiary & it's parent company, NOT giving either of them exclusive rights to a drug for pregnant women

http://www.medreview.us/content.php?_p_=270&sitename=nyc

FOR IMMEDIATE RELEASE - St. Louis, Jan. 28, 2009 – ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

How many products were recalled? LOTS!
Products Recalled to WHOLESALE Level:

Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)
Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)
Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)
Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)

Products Recalled to RETAIL PHARMACY Level:

Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)

[WinkyDink]

7. No greed here, folks. Run along now.

[katnapped]

14. Yea, relax folks!

Obama got dis!

Change we can believe in! WHOOOOOOOOOOO

[Thor_MN]

9. This is a sequence of events

FDA gave approval for use for this purpose and rights to the company.

The company decided that meant it could charge whatever it wanted, since it was given a monopoly.

What SHOULD happen now is that the government informs the company that if the price is not moved back, it will lose that approval to be sole manufacturer.

If the GOP doesn't like the sole rights being removed they can go F themselves, as they are all about "letting markets set prices."

[Turborama]

11. We lost our baby after 8 weeks last year. My wife is now 15 weeks pregnant & we are using this drug

At least I think it's this one that's mentioned in the article. Allylestrenol: http://en.wikipedia.org/wiki/Allylestrenol

So far the baby is growing healthily and we are now into the 2nd trimester. Still nervous and find it hard to get excited after what happened last time. Hopefully once we can feel his/her movements it'll really start sinking in and we can start getting excited again.

BTW we live in Indonesia and pay about $1:50 per pill.

[Divernan]

13. Hope all goes well for mother and baby.

I think this is a different drug because it is a liquid given in weekly injections.

[cbdo2007]

15. Sorry for your loss last year. Good luck to you this time around!

After losing one, you'll probably still be nervous up through delivery, but there are many exciting moments along the way :)

[Auntie Bush]

23. How come you can buy it for $1.50 and in the US we pay $1500?

What an outrage. Would your wife be taking it if you lived in the US? Good luck with this pregnancy and please keep us updated.

[Auntie Bush]

17. Why is any company given exclusive rights to make and sell drugs?

They have no competition and can sell for any amount they want. Why can't the gov have some price control in these case?

[jmowreader]

20. I could understand $1500/dose if it was something exotic and rare...

made with the dust from fairies' wings and lovingly brewed in gold-plated crucibles.

This is something any compounding pharmacy can make, and make a profit on at $20 per dose. There is no reason at all this shit needs to cost $1500 per dose. If anything it should be LESS expensive now because they can make big batches of it.

[Lyric]

25. What's particularly awful about this case is that the pharm company DIDN'T have huge R&D costs.

I read another article about this a few days ago. The only "costs" to this company are the costs involved in the big clinical study that they're doing--a study that was begun for the purpose of making their bid to "adopt" this orphan drug look as good as possible to the FDA. It's not like this is a brand-new substance that we've never used, and have no idea what the human effects will be.

I also read that the March of Dimes originally supported this because they thought that having a company officially responsible for the drug might make it more widely-available to pregnant women. Now they're dismayed, because the price could have the exact opposite effect.

Supposedly the company is going to make sure that low-income women can get the drug either cheap or free, but I pity the middle-class women who don't technically qualify for the aid program, but who also can't afford it out-of-pocket. Either their insurance premiums are going to go through the roof, or they're gonna have to raid their retirement funds to pay for it.

Maybe the FDA will step in and raise hell about it. I don't know. But we should start pushing for reforms about situations like this. Companies shouldn't be granted exclusive rights to inexpensive orphan drugs without some price regulations in place.

[gkhouston]

27. Companies shouldn't be granted exclusive rights to inexpensive orphan drugs, period.

There's no legitimate reason for the FDA to have granted exclusivity here. It was done to crowd out the compounding pharmacies, which would have gone on providing compounded equivalents of this "new" drug at a reasonable price. Shame on the FDA.

[BuddhaGirl]

22. Big Pharma greed!!

:puke: :puke:

[elehhhhna]

24. It'll get Ameica working again! Once you lose the baby you go back to work.