Politics Play in the FDA's Thesis

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Press releases can provide indications of the motivations behind the approvals in their subtext. I would look to uncover evidence of communication between the White House or Congress and the FDA, indicating that some approvals be given priority. These may be found in press clippings or via the Freedom of Information Act.

There should also be evidence of health outcomes for past accelerated approvals. A study of these, measured against conventional approvals with respect to their effectiveness can determine the differences in the outcomes of the two processes.

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In particular, attention should be paid to the negative outcomes -- for example in H1N1 the incidence of children becoming sick from a mis-dose of the vaccine. By establishing common measures of success, and researching health outcomes of accelerated approvals, the efficacy of such approvals can be measured against evidence of political pressure to make those approvals......

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