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

[Dylon]

So i thought this is too far now, its been bad enough but now they really are trying to control the birth rate. Women that are at high risk of preterm labor have to be wealthy to be able to use this drug now.

And with the FDA apparently not caring about humans this just means that everything that the FDA deems "safe" couldn't even be save at all and were taking the pharmaceutical drugs without knowledge of what could actually be in it.

http://www.naturalnews.com/031684_FD...#ixzz1GWPH28J5

(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_B...).

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_h...).

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/Newsr...).

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.

[SephYuyX]

Seems like Darwinism to me.

[Penthesilea]

Dumb.

It's already existed as an FDA approved drug under a different name.

Insurance companies cover the 1500, the patients most likely pay 10-50 depending on their plan.

[Skjie]

Except then the Insurance raises rates to cover costs, etc.

[Penthesilea]

They do so without a care now anyways. Regardless, you're paying for the standardization and QC for the product, something not guaranteed when it comes from a compounding rx (I'm talking out my ass, I don't know how they operate when making their formulations or whatever).

[Chicomagiko]

They do so without a care now anyways. Regardless, you're paying for the standardization and QC for the product, something not guaranteed when it comes from a compounding rx (I'm talking out my ass, I don't know how they operate when making their formulations or whatever).

Stop posting.

[Penthesilea]

You're a registered pharmacist that works in a hospital pharmacy doing compounding? Let us know what kind of checks there are when making up the drug for injection.

[Chicomagiko]

So your sole response is to state a related career/job? Are you implying that you're a pharmacist who doesn't know how his/her own industry works?

... I'm talking out my ass, I don't know how they operate...

Amazing not really.

[Kerberoz]

http://www.natural

Stopped reading here.

[Correction]

What prevents doctors from simply administering progesterone instead of this drug?

Is Dylon our new Vajra?

[Penthesilea]

You're right I'm not a pharmacist, but I work in drug discovery for Pharma and the article is a joke.

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

Good thing there's no bias in the article... Not quite sure if the authors understand how much money it takes to even pursue something preclinical...

[archibaldcrane]

Stopped reading here.

This. Troll website is troll.

[Penthesilea]

What prevents doctors from simply administering progesterone instead of this drug?

Is Dylon our new Vajra?

No one else has an FDA approved license to manufacture it. It was previously unregulated by the FDA and while it appears to be pretty easy to formulate, there was no real reason to hold onto it by Squibb (the previous manufacturer). Now that studies supporting it as an early term labor drug, published since it was no longer marketed, someone decided to make it again in a controlled environment (not by compounding RXs)

[MaachaQ]

Cheaper version of pricey preterm birth drug OK, officials say
Cost had skyrocketed after a company won right to exclusively sell it

By MIKE STOBBE

ATLANTA — Pregnant women will still be able to get a drastically cheaper version of a new expensive drug that prevents premature birth, federal health officials said Wednesday.

Since the drug was approved, it's been unclear whether women would have to pay $1,500 per dose for the licensed version or could continue to have it made by specialty pharmacies for $10 to $20.

The price increase caused an outcry, and the Food and Drug Administration on Wednesday took the unusual step of declaring that pharmacies can still make the cheap version of the once-a-week shot on an individual basis, as they have for years. The agency said it wouldn't step in unless there was a problem with the safety of the specially made version.

In response, KV Pharmaceutical Co, which makes the drug named Makena (mah-KEE'-nah) said it was committed to making sure all women who need the drug have access to it. The company said it plans another announcement by the end of the week about the drug's price.

The drug helps prevent premature births in women who previously delivered early.

Doctors and others had welcomed the FDA approval of the drug last February, but were stunned when the $1,500 per dose price was announced. Total cost during a pregnancy could be as much as $30,000.

The FDA does not control pharmaceutical pricing. The company said the price was justified because the drug can prevent premature births that can result in mental and physical disabilities, and because it spent millions bringing the drug to market.

Last month, the company sent a letter to special pharmacies across the country, warning them to stop making the cheaper version or they would face FDA enforcement. An FDA spokeswoman initially said the company's letter was accurate. But on Wednesday, the FDA stated that wasn't right.

The FDA has become increasingly aware of public worry and anger over whether women would still be able to get the drug, and whether government Medicaid programs that serve the poor would still be able to pay for it, federal officials said.

"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 the drug, a form of progesterone also known as 17P, the statement said.

The FDA's action was applauded by the March of Dimes, which initially had a muted reaction to Makena's cost but has become more forceful in calling for a price reduction. The announcement "lays to rest any ambiguities about whether specialty pharmacies can continue to compound 17P. It would be a tragedy to interrupt access to this important drug," a statement from the group said.

"FDA's announcement is a victory for pregnant women, consumers, and taxpayers," said U.S. Sen. Sherrod Brown, an Ohio Democrat who has called for a federal investigation into Makena's pricing.

Experts say the Makena situation is unusual. More commonly, pharmaceutical companies develop a new drug and — after it comes on the market — some pharmacies may try to make a version of the licensed drug. But in this instance, pharmacies were making it before KV.

What's more, the FDA's regulation of special pharmacies is "a gray area" based on agency policies, not laws, noted Alvin J. Lorman, a respected Washington, D.C.-based food and drug lawyer.

KV, based in suburban St. Louis, previously announced a patient assistance program that would discount the price for women who met certain guidelines. The company said Wednesday it was "exploring additional ways to help provide affordable access for all patients who are prescribed Makena."

Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

http://www.msnbc.msn.com/id/42342822...alth-pregnancy

[Mazmaz]

I can still totally see them getting doctors to shove the expensive version down the throats of uninformed pregnant women. But hey at least some good news.

[aurik]

Not that big Pharma isn't evil. Here's a story that should make you seething mad if you know anyone that suffers from cancer:

http://www.rinr.fsu.edu/fall2002/taxol.html

[Enkidu]

Not that big Pharma isn't evil. Here's a story that should make you seething mad if you know anyone that suffers from cancer:

http://www.rinr.fsu.edu/fall2002/taxol.html

Glanced over, but why should that make cancer patients mad? These are the people working day and night trying to cure them. And most of these people are not making a lot of money doing so - only the ones who succeed make bank.

[aurik]

Because Bristol Meyers Squibb is deliberately impeding the progress of science for the purpose of their own profit?

[plue]

I'm not familiar with NaturalNews, the website that featured OP's article, but it seems to me that they're a bit biased. It read to me as more of an attack than an informed article, although I should mention I'm not overly familiar with the issue at hand.