FDA

FDA grants monopoly over preterm labor prevention drug: 15,000 percent price increase then announced

Sunday, March 13, 2011 by: Ethan A. Huff, staff writer
Tags: FDA, drug monopoly, health news

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Delicious
(NaturalNews) Still think the US Food and Drug Administration (FDA) has your best interests in mind? According to new reports, the agency has arbitrarily decided to grant exclusive approval to KV Pharmaceutical to produce the one-and-only FDA-approved premature birth prevention drug -- which is really just a modified, patented version of the common hormone progesterone -- administered to women with a high risk of preterm delivery. So what used to cost women as little as $10 to buy from their local compounding pharmacy will now cost $1,500, thanks to the FDA.

Progesterone injections have long been custom-made by compounding pharmacies and sold for very little to women in need of them because, frankly, they cost very little to produce. But a backroom deal over at the FDA has changed everything, allowing a single pharmaceutical company to gain monopolistic control over the drug, which in turn allows that company to charge whatever it wants to for the injections, even if it is thousands of times more than what the drug actually costs to produce.

"This is a huge increase for something that can't be costing them that much to make," said Dr. Roger Snow, deputy medical director for Massachusetts' Medicaid Program. "For crying out loud, this is about making money."

And Snow is exactly right. The costs associated with producing progesterone are minimal, and there is absolutely no justification for charging $1,500 -- or as much as $30,000 throughout an entire pregnancy -- for progesterone treatment. But the FDA decision and the subsequent price increase are a natural result of what happens when government regulatory agencies are bought and paid for by the very industries they are supposed to be regulating.

In case you missed it, NaturalNews recently covered the release of the Light and Warburton study, which explains how drug companies essentially lie about their research and development (R&D) costs, use those lies to convince the government to let them charge whatever they please for drugs, and rake in billions of dollars in profits every year. And one of the worst parts about these lies is the fact that the People are usually the ones who actually pay for a good portion of this R&D via their tax dollars (http://www.naturalnews.com/031657_Big_Pharma...).

On the same note, the recent FDA decision in favor of the KV Pharmaceutical monopoly on preterm prevention drugs fits the R&D lie equation perfectly. Not only does the Makena drug in question cost very little to make, but the R&D costs for its development were largely footed by grants and other sources of funding, not by KV Pharmaceutical.

So how are the FDA and KV Phamaceutical getting away with this crime against humanity? For the exact same reason that every other FDA / drug company collusion effort goes largely unnoticed and unpunished -- drug companies essentially do what they want, when they want, because they basically own the FDA and the mainstream media, both of which regularly do their bidding.

Remember, the FDA legacy is practically built on corruption and blatant criminal behavior. In 2009 alone, numerous drug companies were exposed for committing scientific fraud, lying to doctors, fabricating studies, creating "hit lists" of their enemies, hiding the truth, intentionally misbranding drugs, fabricating review boards, and committing other felony activities. Not once did the FDA attempt to actually do the right thing in any of these cases, instead choosing to spend taxpayer dollars targeting natural health companies, seizing anti-cancer herbs and other natural medicines, raiding raw dairies, and imprisoning innocent people (http://www.naturalnews.com/027851_health_new...).

The Makena approval fulfills another FDA agenda of eliminating the existence of compounding pharmacies, too. Instead of allow women to receive customized, inexpensive, and FDA-unregulated treatments, the agency would rather force the public to buy a single FDA-approved version for 150 times the price. And in this case, KV Pharmaceutical will rake in billions, the FDA will receive its million-dollar application process payoff, and the public will foot the bill for the extortion. This is just how the FDA rolls, after all.

What is even more absurd in this case is the fact that the FDA approved Makena without any substantial evidence that the drug even works. According to an FDA press release issued on February 4, 2011, KV Pharmaceutical "must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit" (http://www.fda.gov/NewsEvents/Newsroom/Press...).

The reason for this little caveat is probably because the study that the FDA cites in its release as preliminary evidence of Makena's safety and effectiveness shows a near-negligible benefit in preventing preterm delivery. So not only has the FDA flagrantly slapped the public in the face by approving the drug in the first place, but it has done so in a wholly unscientific and offensively absurd way, informing the public that the "safety and effectiveness" studies will come later -- but go ahead and start using the $1,500 drug now.

The truth of the matter is that unregulated, customized progesterone injections at $10-a-pop are just not something the FDA can tolerate. The scenario was simply too good of a profit opportunity for the drug industry and the FDA to pass up. So they swooped down, seized it, created a monopoly out of it, and are now going to rip off the public in the name of science.

It remains to be seen just how much longer the American people are going to put up with what can only be termed the new normal in mainstream American medicine.

Sources for this story include:

http://www.suntimes.com/lifestyles/health/42...

http://www.cbsnews.com/8301-504763_162-20041...

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