Tuesday, April 27, 2010

Big Pharma Roast

CSpan had some government bureaucrats patting them selves on the back for fining drug maker Astro-Zenica billions of dollars. Astro-Zenica's crime? Marketing drugs for "off label" uses. Terrible crime that. Normally I'm as ready as the next guy to roast a drug company. They charge ridiculous prices, waste enormous sums on marketing, and haven't developed much in the way of new pills lately.
But marketing drugs "off label" is pretty harmless. A new drug (call it Wondermycin) is taken to the FDA and after much time, mountains of paperwork, and probably some under the table payoffs, the drug is approved for sale. The approval reads something like this. "Drug Wondermycin is approved for treatment of this, that and the other disease". Those are the "on-label" uses.
Later on it is discovered that Wondermycin is also good against a couple of other diseases. (Off-label uses) Word gets out to the medical community and doctors begin the prescribe Wondermycin for those other diseases. "Word gets out" means the Wondermycin salesmen tell the doctors about the "off label" uses.
This infuriates the FDA. FDA feels that the drug makers should submit more mountains of paperwork, run more expensive clinical trials, and grovel before the desks of FDA bureaucrats in order to obtain a new approval listing the additional uses. Naturally, the drug companies, after the terrible beating they took getting Wondermycin approved in the first place, are unenthusiastic about going back to get beaten up a second time.
In actual fact, off label uses are carefully controlled. The doctors, for ever looking over their shoulders for a malpractice lawyer hiding in the hallway trash can, are not about to write a prescription for off label use unless said off label use is super safe. No doctor with two brain cells firing is going to risk a malpractice suit by causing harm to a patient. The doctors all know that should a patient suffer so much as a hangnail after taking a drug for an off label use, they will get sued down to their socks.
So, FDA and the bureaucrats are fining Astro-Zenica for promoting off label use, even though off label use isn't going to hurt anyone. This is bending the cost curve UP, and doing it just to make the FDA bureaucrats feel all warm and fuzzy.

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