The first paragraph says it all:

“The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug — a copycat of the antidepressant Wellbutrin XL — was not the equivalent of the original drug produced by GlaxoSmithKline since 2003.”

It took the FDA nearly 10 years to admit to a failure. How many people were hurt as a result? How many people will lose their jobs? The answers are probably at opposite ends of the numeric spectrum.

Being a good, bureaucratic, non-responsibility-taking agency, the FDA said this in 2009 (6 years after they knew there were problems):

“in 2009 responded to public concerns by flatly declaring Teva’s Budeprion XL “bioequivalent and therapeutically equivalent to (interchangeable with) Wellbutrin XL 300 mg.””

Wrong and lying. These are the people that we’ve entrusted to protect us.

I extol the virtues of the market for fixing problems. It should be noted that the market makes mistakes. But the market corrects its mistakes. The government? Not so much. The virtue of the market is often realized in contrast to the alternative: the market versus the government. The government has clearly failed. The market might fail, but it does so openly, honestly (when the government isn’t also involved), quickly, and it then fixes its mistakes. The FDA still hasn’t really fixed this mistake; the core policy (all generics are equivalent to non-generics) still basically holds at the agency.

Finally, in the spirit of Evolve, a member of a FDA watchdog group makes this astute observation about the unbending-ness of reality to kingly decrees:

“The FDA is not infallible,” write Joe and Terry Graedon, who publish the column “The People’s Pharmacy,” and run an online forum by the same name. “Just because the agency says all generic drugs are identical to their brand-name counterparts does not make it so.”

Indeed. As Ayn Rand would say, “Reality, to be commanded, must be obeyed.” Or, as Aristotle would say, “A is A”. Simple, no? Too bad the FDA can’t figure it out.

-JD Cross

 

 

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