New economic analysis shows that FDA proposed generic drug labelling regulation would result in $4 billion in new health care costs

A recently proposed Food and Drug Administration (FDA) regulation affecting generic drug labeling would result in an estimated $4 billion in additional U.S. health care costs annually, according to a new analysis by economic consulting firm Matrix Global Advisors (MGA).
The FDA's Proposed Rule would permit generic drug manufacturers to initiate changes to their labels, which they currently are prohibited from doing. The agency insists that the rule would "generate little cost," but MGA finds that it would dramatically alter the legal and financial landscape for generic manufacturers and suddenly expose them to product liability lawsuits (Press Release MGA, 5 February 2014).
Click here to read the full press release.
Click here to download the full report (251 kB).

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