Drug that's been around since 1956 KV Pharmaceuticals 15,000% price increase

[RamboLiberal]

It's probably safe to say that most of politicians have never heard the word "Makena." But, they're hearing it now, thanks to KGUN and outraged voters. With government help, privately held KV Pharmaceuticals has jacked up the price of this medicine by 15,000%!

What a difference a fancy name makes. Hydroxyprogesterone, now used to stop premature birth, has been around since 1956. For the last five decades, its cost was next to nothing. But, when KV Pharmaceuticals got FDA approval recently and hydroxyprogesterone became Makena, a whole lot more than just the name changed. The typical course of treatment that used to cost about $200, skyrocketed to about $30,000. Company spokespeople have justified the price explosion by pointing out that the company plans to conduct expensive new studies on this half-century-old drug. 9 On Your Side asked if KV Pharmaceuticals is doing anything differently in the manufacturing process that would justify such a huge increase. They would only reply that its facility is regulated by the FDA, a distinction that some pharmacists laughed off.

The price hike has sparked widespread outrage. Many have questioned why a company would make a drug that prevents pre-term labor inaccessible for most pregnant women. KGUN9 News took advantage of U.S. Senator John McCain's Tucson visit to ask him about it.

"As you know, I've always been in favor of generic drugs and fought against the drug companies with their powerful lobby. And, not only prevented the rapid movement of generic drugs to the market, but they have actually done things like pay generic drug makers not to make a drug," said McCain. But, Makena appears to be a case of generics in reverse; going from a widely produced drug to a pricey monopoly for just one company.

http://www.kgun9.com/global/story.asp?s=14318531

Backlash builds over KV's 'outlandish' price for prenatal drug

In a securities filing on Tuesday, KV Pharmacuetical Co. acknowledged that it had received a torrent of criticism over the high price of its newly approved prenatal drug, Makena, and that it could face challenges in getting the government and insurance companies to pay.

The disclosure amounts to the Bridgeton-based drugmaker's first public admission that public pressure and politics threaten to derail its plan to charge $1,500 a shot for an FDA-approved version of a drug that now costs about $15.

The company's growing list of critics includes some heavyweights, among them two U.S. senators — who have called for a Federal Trade Commission investigation into the drug company's pricing — several members of Congress, the March of Dimes Foundation, the New England Journal of Medicine, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics.

An official at the March of Dimes — which effusively praised the Food and Drug Administration's decision last month to approve Makena — called KV's price "outlandish" on Tuesday.

http://www.stltoday.com/business/local/article_bda7ebe9-ee6c-5d8b-b4e8-09daf6399ede.html

My local paper Pittsburgh Post-Gazette covered this last week. Compound Pharmacies were making this drug in price range of $10-$20 a dose. Total costs would've been around $300. Of course health insurance companies are now refusing to approve it. Glad to see even a Repub like McCain is paying attention to these greedy bastards!

[revolutionnow45]

1. good- I hope Republicans really start looking at these health care ripoffs

They complain complain complain about spending....how much is wasted allowing insurance companies and big pharma to jack us like this?

Wake up Republican morons!! WE were trying to fix health care for a reason. NOT FOR PROFIT was for a reason!!!

You want your tax cuts? Then cut off the extortionists.

[FiveGoodMen]

2. Tell the president. He won't let Big Pharma get away with this!

(If you need the tag...)

[azul]

3. This is a gift to big pharma, increasing cost for meds

and making opportunities for businesses. Businesses that spend more on advertising than research. I have seen it happen to many drugs over the last few years. They tried to take morphine off the market last year, for pete's sake, and it created enough stir to force the FDA to relent (killing hospice care).

The company that does the research gets the exclusive patent rights on these already usefully effective drugs.

What prodded the FDA now?




"Since 2006, the agency has taken more than 500 unapproved drugs off the market, according to Michael Levy, a division director in the F.D.A.’s Center for Drug Evaluation and Research.

Essentially, the F.D.A. is working its way through a decades-old backlog of unapproved drugs. Many standbys, including morphine, were sold in this country without F.D.A. approval because their makers considered them to be grandfathered drugs — medicines that were on the market before the establishment of the agency in 1938.

But in recent years, the F.D.A. has challenged that interpretation. In 2006, it started a program to encourage makers to submit any unapproved drugs for agency review. It also began removing many unapproved ones from the market.

Mr. Levy said a drug maker seeking to be covered under a pre-1938 exemption would need to submit evidence to the agency showing, among other things, that its drug had the same dosage and labeling as a medication sold before 1938."

http://www.nytimes.com/2010/03/27/business/27nitroside.html?_r=1

[notadmblnd]

4. this should get the anti-choice people's panties in a bunch

They're killing babies!