What Does it Take to Get a Black Box Warning?

Thursday, June 07, 2007
By: Byron J. Richards,
Board Certified Clinical Nutritionist

Critics of the FDA and Big Pharma have for years complained that the FDA stifles needed health warnings so as to allow pharmaceutical companies to gain market share and profits at the expense of human health.  This is certainly the case with antidepressants, ADHD drugs, and atypical antipsychotics.  A classic example of this problem has come to light as part of the Avandia scandal.

The FDA announced it will now put a black box warning on Avandia for congestive heart failure.  This comes after a rather shocking revelation in the New England Journal of Medicine, which revealed huge problems with Avandia safety.  The FDA has been fully aware of the safety issue for some time, doing nothing while the drug climbed to 3.2 billion in sales.  Only when Congress schedules FDA executives for a hearing wherein they know they will be grilled on the topic does the FDA respond.

On June 6, 2007 the New York Times revealed a stunning event that occurred in March of 2006 wherein FDA safety supervisor Dr. Rosemary Johann-Liang approved a black box warning on Avandia to warn about the risk for congestive heart failure.  The von Eschenbach team ordered her to retract her approval of the warning.  She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia. 

The safety of human health should not be in the hands of those working on behalf of Big Pharma.  The current FDA “drug safety” legislation (S.1082/HR.2900) does nothing to change corrupt FDA management.  A major overhaul is truly needed.

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