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FDA Requirements Block Effective Treatment

November 14, 2006

The Wall Street Journal reported yesterday (Monday, Nov. 13, front page) on a doctor's frustrations with a company that refuses to sell in the U.S. what he believes is a very effective treatment for infants with short bowel syndrome. The treatment is a new formula called Omegaven, based on fish oil, which does not appear to have the negative effects on the liver that other formulas have. The headline in the WSJ implicates the manufacturer, but the text reveals a reason for the company's reluctance: expensive FDA red tape.The article reads,

...Dr. Puder's effort to get Omegaven widely used in babies has put him in an unusual conflict with the German company that developed the drug. Fresenius Kabi AG, which makes Omegaven, says it isn't interested in bringing the drug to the U.S. market. The company says it doesn't agree that Omegaven is the best drug for these babies and has a new product that it believes is better.

and later in the article...

Fresenius Kabi says it doesn't want to invest the resources required to test both products for approval by the U.S. Food and Drug Administration. It hopes to eventually sell the new product in the U.S., ...although no timetable has been set and no trials are under way.

The FDA is playing helpless, as though they cannot change their own regulations:

"There is not a whole lot that FDA can do," if a company isn't interested in selling a product in the U.S., says John McCormick, deputy director of the office of orphan-products development at FDA. If the maker of a product has a patent on it, "they can do anything they want with it."

In the meantime, the only way to use Omegaven for these infants is to go through the procedure the FDA has for "experimental" drugs.

Because Omegaven is considered experimental in the U.S., if hospitals want to try it, they have to ask permission from the FDA for each individual patient. The FDA has regulations that enable doctors to use experimental drugs in certain emergency situations.
If hospitals obtain the required permissions, they must then find a way to buy the drug on their own, since insurers typically won't cover Omegaven because it's experimental. The cost can run from $50 to $100 a day per patient.

There is bureaucracy wherever you turn. A Google search for Omegaven yielded, among other hits, the manufacturer's UK website, which would not allow me access to information on the drug. The website revealed yet another "consumer protection" regulation that seems to be a blatant protection of the medical and pharmaceutical professions' profits:

Please note that the following pages contain information on prescription-only drugs. Under British consumer protection law, Fresenius Kabi must not make this information accessible to individuals who are not member of the medical or pharmaceutical professions. Accordingly, we have restricted the access to the following pages and invite you to register for an user-id and a password. We assure you that registrations will be processed as soon as possible. All personal information you may choose to supply will be handled in accordance with British and international standards of privacy.

I do not have the link to the WSJ article (if a reader with a subscription to the online WSJ will e-mail me I'll post it), but here is a similar story in the Boston Globe.

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