New F.D.A.: Transparence and Flexibility

[TomCADem]

Source: NY Times

WASHINGTON — During the Bush administration, the Food and Drug Administration was mostly a place of black-and-white decisions. Drugs were approved for sale or they were not, and the agency’s staff was expected to publicly support those decisions.

But as Thursday’s landmark decision on the controversial diabetes medicine Avandia makes clear, things have changed under the Obama administration. Certainty, staff unanimity and even the approval status of big-selling medicines are no longer so black and white.

Presented with what seemed to be a choice between keeping Avandia on the market or withdrawing it, the Obama administration decided on an unusual middle path — allowing sales, but with tight restrictions. Even more unusually, the agency admitted that many of its top scientists disagreed, some passionately. Competing memorandums were posted immediately on the agency’s Web site.

And the agency’s three top officials co-wrote a highly unusual explanation of their action in The New England Journal of Medicine.


Read more: http://www.nytimes.com/2010/09/25/health/policy/25avandia.html

[PSPS]

1. "Flexibility" = Bendable to accommodate big pharma's insatiable desire for profit$

[nosmokes]

2. yeah right, that's why we're still the ONLY developed nation that doesn't require labeling

of genetically engineered(GE or GMO) foodstuffs despite numerous studies showing possible harm. And they're about to OK GE salmon despite hundreds of thousands of comments requesting more study.Meet the *new* FDA, same as the old FDA.