David R. Henderson  

The Feds' Attack on Forest Laboratories

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At first, the FDA "grandfathered" older drugs. But in 1997, the FDA decided that some older drugs were actually "new drugs." Therefore, Forest needed to navigate the FDA's expensive and difficult new drug approval process. Forest didn't act quickly enough to follow all the proper procedures and violated the FDA's deadlines. FDA Commissioner Margaret M. Hamburg claimed that the government is going after companies that "pursue profits over the public's health." She knows better. Forest was trying to make profits by improving the public's health.
This is from Charles L. Hooper and David R. Henderson, "The Federal Government Bares Its Teeth At A Pharma CEO" in yesterday's Forbes.com.

In threatening not to buy drugs from Forest Laboratories unless it fires its CEO, the feds are taking a major step toward taking over companies.

What was Forest's other sin? Promoting off-label uses. Who else does that? Almost every doctor in America--and the federal government. Here's another excerpt:

And here's the irony. The U.S. government itself, through the Medicare program, for example, regularly pays for drugs prescribed off-label. Moreover, the government itself sometimes funds studies for off-label uses. The National Institute of Health National Eye Institute, for example, funded a clinical trial of Genentech's Avastin, already approved for cancer, for use on wet age-related macular degeneration. And the results, which came out last week, are promising. If off-label usage threatens public health, then Medicare and the NIH never got the memo.

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Shangwen writes:

This reads like another example of White-Knight pharmophobia in the guise of "safety". It reminds me of the Mental Health Parity Act, which was a way for the government to be seen as conspicuously beating up on insurers, even though it was no surprise to see mandatory parity lead to treatment becoming less accessible because of rising costs.

I have a comment on a related phenomenon in Canada, which certainly confirms the widespread existence of non-standard pharmacotherapy practices.

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