Letter to FDA Regarding Proposed Changes to Generic Drug Labeling

April 22, 2014

Excerpt: The process followed by FDA in proposing this rule appears to stand in stark contrast to the approach taken by the agency in developing changes to the content and format of prescription drug labeling under the Clinton administration. At that point in time, FDA determined that ‘the use of labeling in product liability and medical malpractice lawsuits, together with increasing litigation costs, has caused manufacturers to become more cautious and include virtually all known adverse event information, regardless of its importance or its plausible relationship to the drug’ and that the ‘increase in length and complexity of prescription drug labeling’ has made it ‘harder for health care practitioners to find specific information and to discern the most critical information in product labeling.’

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