Posted on 03/23/2011 7:02:48 AM PDT by La Lydia
When a new FDA drug-and-money scandal has doctors, US senators, and even the March of Dimes in an uproar, you know it’s bad. A drug which the FDA approved more than half a century ago—which doctors have been prescribing for their patients with high-risk pregnancies through compounding pharmacies with great success—was designated by the FDA an “orphan drug.” Now KV Pharmaceutical has been given the exclusive right of production and sale (not to mention drug trial tax breaks!). They immediately raised the price from $10 per dose to $1,500—simply because they could.
The drug is a synthetic form of progesterone given as a weekly injection. It has been made cheaply for years and produced in compounding pharmacies. The price hike means that the total cost during a pregnancy could be as much as $30,000.
Doctors say the $30,000 price tag will almost certainly deter low-income women from getting the drug, leading to more premature births. Dr. Roger Snow, deputy medical director for Massachusetts’ Medicaid program, was quoted as saying, “That’s a huge increase for something that can’t be costing them that much to make. For crying out loud, this is about making money!” And Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia, observed, “I’ve never seen anything as outrageous as this.”
Besides the grave jeopardy placed on the mothers and their infants, this will create a huge financial burden for the health insurance companies, private citizens, and government programs that have to pay for it. In the long run, because of birth complications, the babies will need to be hospitalized for perhaps months—and, for low-income mothers, all at the expense of taxpayers. On top of that, lung issues at birth can have lifelong repercussions on the individual’s health with an increased propensity toward asthma, bronchitis, and pneumonia, among other early birth issues.
The March of Dimes—a nonprofit organization dedicated to preventing birth defects—received funding from KV Pharmaceutical and supported the company’s New Drug Application. Now the organization has started backtracking in the face of all the public outrage. They just sent a letter to KV “expressing our serious concern about the price of Makena.”...
As soon as FDA gave the drug (now trademarked as Makena) orphan drug status, its manufacturer, KV Pharmaceutical, sent a cease-and-desist letter to compounding pharmacists, stating that “FDA…views compounded drugs to be ‘new drugs’ within the meaning of 21 U.S.C 312(p) and as such they may not be introduced into interstate commerce without FDA approval.”
The Orphan Drug Act is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market, and it has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. But this is a drug which was already developed, already approved, already in use, and has been costing $10 per treatment for many years. To raise the price to $1,500 per injection just because they can is unconscionable....
And we wonder at the spectacle of soaring health care costs.
The revolving door corruption between the FDA and Pharma is well known. It’s the elephant in the room no one wants to talk about when discussing spiraling medical costs.
Frankly, I ain't buying it. Costs don't increase by 150 times because you're making it in an "FDA" approved facility as opposed to mixing it in a drug store.
Certainly, a snake oil salesman has to trick or con you into doing what he wants. A government worker can impose his will with the barrel of a gun.
Ok, a government flak is a snake oil salesman
with a gun.
I’ll side with KV on this one. It’s not their fault — monopolies allow companies to charge whatever they want.
It’s the FDA which decided to shut down all the cheap competitors, and allow KV to have a monopoly and charge what it wants.
I wouldn’t put it past this administration to do this on purpose, to get conservatives riled up and supporting some sort of price controls, or as some here say, to attack the drug company for “obscene profits” giving government the excuse to start regulating prices.
We can’t be tricked like this. The free market gives us correctly-priced goods by providing a system of easy competition. The government mostly interferes with that system. Sometimes that interference is good and constitutional, like patents, which for a brief time let people who develop new things make all the money they can before turning the product over to competitive forces.
But mostly the government just screws things up, like the FDA — in the guise of protecting us from “bad drugs”, they limit the availability of drugs, limit our choice to take our own risks, and sometimes grant monopoly status to companies when there was ample competition.
But since it “does,” they could just farm it out to compound pharmacies and produce it more cheaply and provide it for less.
Does KV support Pubbie or Demonrat pol’s?
How about Canada? (although I doubt I would travel 8 hours round trip just to get it).
“I wouldn’t put it past this administration to do this on purpose, to get conservatives riled up “
Well,,, there’s a comment at the article;
“This does not suprise me. In the United States of Amerika, no longer a “democracy” but rather a fascsit-korporatist plutocracy as envisioned by Mussolini, making huge amounts of money for those who are already wealthy beyond the wildest dreams of Croesus at the expense of the rest of the planet is far, FAR more important than human life.
The filthy Repuke hypocrites need to shut up with the “pro-life” Christianist lies and propaganda, because the ONLY god they worship is MAMMON – to whom the make HUMAN sacrifice in just this way.”
How much do you suppose KV Pharmaceutical, its officers, PAC and employees donated to Democratic politicians. Anyone who voted for Obama has to be out of his mind.
Take a look at their leader...maybe they are raising the price to pay his fines and legal bills?
http://pharmalive.com/News/index.cfm?articleid=767351
;-)
This has nothing to do with Obama, or Bush. And because we are discussing the FDA, not Congress, I can pretty much figure out what happened: Shortly after this decision was reached, one or more FDA staff members suddenly left and went to work for KV Pharmaceutical at very comfortable salaries.
yeah, that stuff was great...tasted like doggie doo, but it worked!!!
No idea about Canada. Try some online pharmacies, there are a bunch of Canadian ones.
The reality is that the federal government is a legalized extortion racket. That entity is no different than the mafia, except they have the backing of the FBI and all other federal LE agencies. Sorry.
The government is the legalized mob.
Ah yes I do remember terpin hydrate with codeine, aka..GI Gin. Talk about a cheap drunk! When I was young, in the 50’s, my doctor would prescribe it.
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