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Entries in KV Pharmaceuticals (2)

Tuesday
Mar292011

FDA May Allow De Facto Generic of Pricey Preemie Drug Makena

Paul Tearle/Thinkstock(WASHINGTON) -- The Food and Drug Administration has no intention of enforcing a regulation that one drug company sought to exploit to drive out competitors, an FDA official told ABC News.

The regulation invoked earlier this month by KV Pharmaceuticals would have allowed the company to corner the market for a drug used to prevent preterm births and sell it for 150 times what had been the going price.

KV Pharmaceuticals gained exclusive rights in February to produce a progesterone shot used to prevent preemie birth that it branded Makena. The shot had been offered by compounding pharmacies for between $10 and $20 per dose, but KV planned to sell it for $1,500 per dose.

The company then sent cease-and-desist letters to compounding pharmacies, saying the FDA would take action against them if they continued to synthesize the drug.

Though the FDA has not made an official statement, an official there, speaking on the condition of anonymity, told ABC News that this "is not correct" -- the FDA would not take action against these companies.

Because the FDA has no control over how companies it grants drug approval set prices, some health care experts said these comments, couched in anonymity, seem like an attempt to lessen the unintended consequences of the decision to grant KV Pharmaceuticals seven years of exclusive rights to the drug under the Orphan Drug Act.

Doctors, however, say they will need more than an anonymous comment to feel comfortable prescribing the unregulated, compounding pharmacy-made version of the drug.

KV Pharmaceutical have responded to the price controversy by announcing a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, KV Pharmaceuticals and partner company Ther-Rx, wrote: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

Copyright 2011 ABC News Radio´╗┐

Friday
Mar112011

Price of Preventing Premature Births Skyrockets

Comstock/Thinkstock(NEW YORK) -- 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.

KV Pharmaceutical's response to the price controversy has been to announce a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, drugmakers KV Pharmaceuticals and partner company Ther-Rx, write: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually who "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

Dr. Alan Fleischman, medical director of the March of Dimes, which supported the FDA approval, says that the company has promised to make Makena available to all, regardless of ability to pay and the March of Dimes "stands ready to watch that process and hold them to their promise."

Copyright 2011 ABC News Radio ´╗┐







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