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Francestown, New Hampshire, United States
I am the owner of Mirrix Tapestry & Bead Looms (www.mirrixlooms.com) and an avid tapestry and bead weaver, among other things. Needless to say, I love my job!

Thursday, April 14, 2011

A Must read post for pregnant women

I am making an exception to my rule of only posting about the creative process because I feel that anyone thinking of getting pregnant or already pregnant needs to read the following article.  This was reported on NPR this week.  It's important for those who might need this drug to know that if your Dr. tells you the prescription will cost $15,000 you can say to him/her:  I know it can be gotten for $300.  This is such a scam by a drug company even the Federal Government was shocked.  And don't be fooled.  This drug company did not develop this drug.  It's been around forever.  They just stole it and then decided that since the cost of a premie (because this drug prevents premature birth) is $51,000 and hence they could charge $30,000 for this drug.  They later cut it in half when the Feds balked.  Since the previous price had always been about $300 . . . well, read on.  Be warned.  This is one huge reason why our health care is so expensive.

I've also posted the FDA statement at the end of the article.


Price Slashed For Drug To Prevent Preemie Births

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ATLANTA April 1, 2011, 05:23 pm ET
The maker of an expensive drug to prevent premature births slashed the price by more than half on Friday, following an outcry over the high cost and moves by federal regulators to keep a cheap version available.
The drug is still pricey at $690 per weekly injection but it is a drastic reduction from the $1,500 price charged by KV Pharmaceutical Co. when it went on the market last month. The company also announced rebates and other steps to give the drug to needy pregnant women at little or no cost.
The price cut came two days after federal officials said they would not stop specialty pharmacies from continuing to make a generic version that sells for $10 to $20 a dose, as has been done for years.
The company got government approval in February to exclusively sell the drug named Makena (mah-KEE'-nah). But the price stunned doctors who prescribe the drug and private and public insurance plans, including state Medicaid programs, that pay for it. The drug is given to high-risk pregnant women to avoid another early birth.
The pricing controversy exploded after The Associated Press reported on the issue early last month, with some members of Congress calling for a federal investigation.
The Food and Drug Administration, which has no say in drug pricing, took the unusual step of announcing that the special pharmacies could still make the cheap version for individual patients if doctors prescribe it. Typically, those pharmacies aren't supposed to make versions of licensed drugs, and KV Pharmaceutical had warned them to stop making the preterm birth drug or face enforcement by the FDA.
But on Wednesday, the FDA said that "to support access to this important drug, at this time and under this unique situation," it would not take action against pharmacies that make the drug.
The agency acted because of the public worries that women won't be able to afford the drug, federal officials said.
The suburban St. Louis-based KV Pharmaceutical had earlier defended its pricing, saying the company is spending a quarter of a billion dollars on the drug's development, including $60 million in research.
Chief executive Gregory J. Divis Jr. had said the $1,500 price was justified to avoid the mental and physical disabilities that can result from very premature births. Preemie care can cost an estimated $51,000 in the first year alone, he said.
KV Pharmaceutical officials were not available for an interview on Friday, said a company spokeswoman.
In a statement, Divis acknowledged that prospective buyers of the drug were not happy. He said company officials were cutting the price because they want to make sure all women can get the drug, noting the "budget challenges facing state Medicaid programs and other payers."
The weekly injection is given for as long as 20 weeks; the price drop cuts the maximum cost of treatment from $30,000 to under $14,000.
KV had earlier announced a patient assistance program to provide the drug to uninsured and low-income women. On Friday, the company announced an expansion of that program, lifting income limits so most women would pay less than $20 per injection. It also offered to cap costs for state Medicaid agencies and health insurance plans.
"They had to respond, they had to bring the price down, because people were so outraged," said Dr. Kathryn Menard, a University of North Carolina specialist who oversees a state program that has been providing the cheap version of the drug to women at risk for preterm births.
She added that $690 is still pricey, and many obstetricians may prescribe the compounded version.
Sen. Sherrod Brown, D-Ohio, an early and persistent critic of the original price, called the cut "a small step in the right direction," but said "KV Pharmaceutical is still putting profit over patients."
The company benefited from nearly $21 million in taxpayer money that was spent on early research on the drug, he noted in a statement.
The drug is a synthetic form of the hormone progesterone. It came on the market more than 50 years ago to treat other problems and was withdrawn in the 1990s, though not for safety reasons.
But the drug got a new life in 2003, with publication of a study that reported it helped prevent early births to women who had a history of giving birth prematurely. Obstetricians began prescribing the drug for more women, but it was only available through "compounding" pharmacies.
Initially, doctors were glad to hear that KV Pharmaceutical was licensing the drug. It meant it would be manufactured in an FDA-regulated facility, with tighter controls and follow-up testing to ensure quality and consistency from dose to dose.
But doctors also say there have been no reported problems with the safety or quality of the cheap version. So for many obstetricians, the perks of having an FDA-approved drug may not make up for its still-high price, Menard said.
Also Friday, the March of Dimes issued a statement announcing it was severing all professional ties with the KV subsidiary that is marketing Makena.
The advocacy group was getting hundreds of thousands of dollars from the subsidiary, Ther-Rx. The March of Dimes had celebrated the FDA approval of the drug back in February, and was at first muted in its criticism of Makena's price.
The organization, which heavily relies on volunteers for fundraising and other activities, came under fire from some of its supporters. In recent weeks, March of Dimes officials pushed for a price cut.
"They trusted this company, and any bit of (financial) support they got from the company is not worth what they're going to lose by continuing a relationship with them," said Menard, who is president-elect of the Society for Maternal-Fetal Medicine.
In a statement, KV called the March of Dimes decision "disappointing."
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Online:
FDA statement: http://tinyurl.com/fdastatement
FDA STATEMENT
For Immediate Release: March 30, 2011
Media Inquiries: Beth Martino, 301.796.7603, beth.martino@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA
FDA Statement on Makena
 
On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.
 
For many years, a version of the active ingredient of Makena, which is a synthetic progestin, has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA has exercised enforcement discretion with respect to most products made through traditional pharmacy compounding. This has included products made from the active ingredient in Makena, hydroxyprogesterone caproate.
 
Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.
 
FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.
 
In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.
 
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