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....
You can sign me onto that petition: abolish the FDA.
Sorta like the bad guys in Mission Impossible 2
I think you are half right. Frankly I would rather deal with snake oil salesmen than with government parasites. Repeal and don’t replace is my opinion.
Abolish the FDA and when the first child is born with birth defects because the parents could not afford the drug, sue the CEO of KV Pharmaceuticals. If the child dies they (FDA and KV Pharmaceuticals) should be held accountable for murder. Jerks.
I work in the pharma industry and am often irritated by uneducated people who do not understand the drug development process and how expensive it is.
This however is not one of those cases. This is pure Big Government bureaucratic lunacy.
INvoke the TRIPS agreement and bust the pharma monopoly with worldwide pirating. I’d rather buy my prescriptions from the BRIC countries than see the pharma monopoly make another dime.
Plus, natural progesterone cream can be bought over the counter at any health food store.
The FDA and our Gov’t are going to drive Americans (those that can afford it) overseas for treatment.
More proof that the very phrase “intellectual property” is a lie: patents and copyrights are government-granted monopolies, pure and simple. The “orphan drug” provision is a particularly obnoxious example of this, as it flies in the face of traditional patent law, in which a patent cannot be granted on something which is “existing art”: scaling up to industrial production something that was being made at pharmacies nationwide might be patentable if the process of mass production were new, but then only using that process would be infringement.
This is also an example of the distinction between pro-business and pro-market that Luigi Zingales makes (cf. Gov. Palin’s recent book, which quotes his ideas approvingly): a state-granted monopoly is anti-market but pro-business. And note the effect: a drastic price-rise in a medical treatment. It makes on wonder to what degree health care costs are driven by anti-market measures like the “orphan drug” provision, allowing patents on “new” drugs which scarcely change the molecular structure of an existing drug for treating the same ailment, or, for that matter, laws that encourage the structuring of health insurance so no price information is transmitted to the consumer of health care.
I wonder if that will be stopped because of this. My OB with my latest pregnancy had me use a suppository because he said it is more effective absorbed than injected.
Follow the money. Who’s who in KV Pharmaceutical stock ownership? hmmm
This smells so bad. There looks to be a big story here and a need to follow the money. If a compounding pharmacy can make it for $10 and KV charges $1500 then there is a lot of cash available to bribe decision makers.
The Fugitive II anybody?
The requirement by the FDA of drugs which have been used for a long time to be officially tested causes problems like this. One example was terpin hydrate. It was a spectacular drug for clearing out my lungs from a really bad cold or bronchitis. I remember getting it in the 1980s when I worked at a drug store and the pharmacist told me “here’s what you want”. But some idiot in the FDA in the 1990s decided it had never been proven to be effective so it was taken off the market. No pharma company wants to put in the money to do full testing because it is out of patent and was only $2-$3 per bottle (cheaper than Robitussin). If they did test it the price would probably jump to $100 per bottle.
Colchicine had a similar situation develop last year, but iirc the cost increase was only around 1000% or so.
Question 1) How did KV Pharmaceutical get exclusive manufacturing rights? The answer to this will certainly lead to criminal investigation.
Question 2) How does a company get “drug trial tax breaks” for an old drug like this?
Question 3) Why are there patents and copywrites that have time periods of 10-15 years?
I would rather deal with snake oil salesmen than with government parasites.
There is a difference?
Oh man, terpin hydrate helped my cough too. It was great. Robitussin pales.
I don’t know where you live, but I think you can still get terpin hydrate at drug stores in Mexico.
they did the same thing with colchicine, the pill went from 10 cents to over 5 bucks a pill and there are no generics.
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