Sunday, March 13, 2011

Sure... Pharmaceutical companies don't need no stinkin' regulation!

If this isn't one of the most egregious examples of corporate greed and the need for regulation of "Big Pharma", I don't know what is. When are those creatures in Congress going to do something that helps us?

Next week, the cost of preventing premature childbirth will skyrocket when a drug given to high-risk pregnant women goes from around $10 a dose to $1,500 a dose. The drug, called Makena, which has been made cheaply for years and is given as a weekly shot, could make the total cost during a pregnancy as much as $30,000. Why? Because KV Pharmaceutical of St. Louis recently won FDA approval to exclusively sell Makena last month. 

By receiving “orphan drug status,” KV’s subsidiary Ther-RX Corp. will now be “the sole source of the drug for seven years.” In justifying the 14,900 percent price hike, KV Pharmaceuticals says that pregnant women will be willing to pay the new price because if they don’t, they could have a premature baby, or “preemie,” which could cost much much more:
The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone.
“Makena can help offset some of those costs,” Divis told The Associated Press. “These moms deserve the opportunity to have the benefits of an FDA-approved Makena.”
The U.S. Food and Drug Administration is not involved in setting the price for the drugs it approves.
The question, however, is not whether high-risk pregnant women would elect to offset further cost by using the drug, but whether they can afford the elevated price in the first place. The issue, doctors say, is that “the price hike may deter low-income women from getting the drug, leading to more premature births.” “That’s a huge increase for something that can’t be costing them that much to make,” said Massachusetts’s Medicaid deputy medical director Dr. Roger Snow. “For crying out loud, this is about making money,” he added. Ther-RX launched a patient assistance program Tuesday to help alleviate the cost for some women.

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