Proposed new safety regulations at the US Food and Drug Administration will require considerable extra work while providing little benefit to public health, according to a survey of top drug companies to be published today.
The survey of 14 pharmaceutical and biotechnology groups by BearingPoint, a consultancy, concludes moves to increase reporting to the regulator of "suspected adverse drug reactions" identified by pharmaceutical companies during clinical trials will be ineffective.
The concerns come at a time when the FDA is under pressure to reinforce drug safety in the wake of recent health scares including side effects of a class of anti-inflammatory drugs called cox-2 inhibitors.
The FDA rule changes that are out for consultation - known by insiders as "the tome" - would trigger extra reporting procedures by drug companies to regulators if a possible causal relationship "cannot be ruled out" between a serious side-effect and a patient taking a company's drug.
That increases the burden of proof from the current requirement, which requires expedited notification to the FDA if there is "a reasonable possibility" that the drug caused the adverse event.
Drug companies estimated the change would double their caseload, and impose extra need for highly-qualified drug safety employees to contact patients who report problems.
Courtesy of Financial Times 2/28/2005
Steve - Why are we not surprised? Should we not just keep the status quo and allow increased deaths and side-effects from drugs? What Big Pharma is really saying here is that they will have to put more dollars into research instead of marketing, which will hurt the bottom line.
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