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¶ … politics play in the FDA's accelerated approvals process and what are the implications of this process for public health?
I want to know the answer because: The FDA approvals process for most treatments is complicated. The industry is facing demands for expanded clinical trials, which is increasing the length of time and the expense of gaining approvals. Yet, when rapid approval of a drug is politically expedient, such as with the H1N1 vaccines, the process is streamlined. To me, this raises some public health and ethics issues. The press release for the H1N1 vaccine approvals mentions that testing was on adults only and "clinical studies under way will provide additional information about the optimal dose in children." Yet parents are vaccinating their children, without any FDA study. Either the normal approvals process is needlessly rigorous or the accelerated approvals process is based on political, rather than health, motivations.
I would find the answer myself by: investigating past accelerated approvals. 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. 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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