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Is the FDA a public watchdog or a corporate sponsor?

This news story is beyond absurd; it smacks of ethics violations. The company awarded the special privilege doesn't even have the excuse of recuperating the costs of R&D! And we wonder why the health care costs go up?

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.
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4 responses to “Is the FDA a public watchdog or a corporate sponsor?”

  1. Sujatha

    Thank goodness, sanity prevails regarding the compounded version:
    http://news.yahoo.com/s/ap/20110330/ap_on_he_me/us_med_premature_birth_drug
    On the other hand, I’m not so sure about this one:
    http://news.yahoo.com/s/ap/20110331/ap_on_he_me/us_prostate_cancer_drug_medicare
    I see that many would love to prolong their life for 4 months on average,even if it comes at the cost of about 1 billion dollars and benefits about 11000 men annually. Can the FDA lean on the company making Provenge to drop their prices?

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  2. Ruchira

    The case of Provenge is a little different from that of Makena which is not a new formulation and was already in use, requiring no new R&D.
    Provenge is a one time vaccine and therefore, a one time cost. Also, the average 4 month prolongation of life applies to men with very advanced cases of prostate cancer who were tested not against a placebo but a frozen form of Provenge. There is very good reason to believe (and expect) that the vaccine if administered in the early stages of the disease, has the potention for substantial benefit. Even in the control group where the average prolongation of life is 4 months, 30% of the patients lived for 3 years longer than those receiving conventional chemo-therapy which in the long run is more expensive and far more toxic. (So far no toxic side effects have been reported with Provenge) Also, if you look up how Provenge is administered, you will find out that it is a highly personalized regimen; not everyone is being injected from the same pool of pre-made general vaccine. The process has to be conducted under extremely carefully controlled conditions over several days requiring separate cell cultures for each patient done under super-sterile enviroment. Each vaccine is individualized compounding targeted specifically toward each patient. Quite a different deal than the well established regimen of injecting pregnant women with progesterone. While I do agree that $93,000 a pop for a drug is excessive, the marketing of Provenge is not nearly as egregious as KV pharmaceutical monkeying around with Makena. BTW, following the FDA’s remorse and the wildly bad press, KV has now reduced the price of Makena to $600, still a 40-60% increase from the customary price. March of Dimes, which has lobbied the FDA on behalf of KV (MD was concerned about the purity of the product) has withdrawn its support.

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  3. Sujatha

    Thanks for the clarification on the situation with Provenge, Ruchira. Given the complexity involved,it’s obvious that they wouldn’t be willing to drop the price that much. One wonders how much of the $93,000 is profit and how much actual cost, I wouldn’t be surprised if it has been inflated by a factor of 50, easily.

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  4. Ruchira

    Oh, I am sure that the price of Provenge is inflated – I don’t know by how much. The company went nearly bankrupt and spent a bundle on research and trials. It is time to recoup the losses and then some more! I was pointing out the difference between the actual efforts made by Dendreon and KV. The latter did nothing productive for the drug it is selling, except act like a vulture and that too riding on the reputation of unsuspecting backers like the March of Dimes.

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