Cutting Edge Information specializes in paid research reports for pharmaceutical decisionmakers, but yesterday sent out a press release not plugging a new report but simply opining on what lessons will be learned from the rapid and, it appears, successful development of new vaccines to tackle the swine flu pandemic. And what's to be gleaned from how quickly these drugs were approved by global regulators?
CEI raises some salient issues: if H1N1 vaccines can be successfully fast-tracked, shouldn't this open the door for more rapid and favorable regulatory review of oncology drugs and other products that clearly
deserve more urgent attention than they are getting (and whose approvals perhaps shouldn't be delayed in lieu of full safety and efficacy data)?
Another issue: Will politics play a larger role than it does now in pressuring regulators to act? H1N1 has been a clear case of needing immediate industry action and regulatory response, but will manufacturers now leverage public fears to garner special regulatory treatment?
The New York Times has been exploring issues such as these in its excellent Forty Years' War series devoted to coverage of cancer drug research and development. A recent installment looks at Dr. Richard Pazdur, director of FDA's cancer drug office, and the dilemmas he faces in reviewing potential cancer therapies, and the charged political environment that surrounds his decisionmaking.
Once H1N1 is addressed (for this flu season at least) and we have lessons learned from the current wave of the pandemic, there will be ample discussion around what we have learned, and what we can apply to bring important drugs to market sooner rather than later.
--Paul Thomas
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