From a new article by David Henderson and Charlie Hooper:
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
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 …
Have a lovely evening. I am sure this is exactly what “necessary and proper” means.