While FDA’s OTC drug monograph system is an “appropriate and rational framework” for regulating cosmetic-drug products, greater transparency and more regular communication with industry are needed, according to the Personal Care Products Council’s Elizabeth Anderson, executive VP-legal and general counsel, who offered comments March 25 at a public hearing on potential improvements to the process.
There is nothing wrong with FDA’s over-the-counter drug monograph system – as designed – but marked improvements are needed for the system to function at a level that promotes industry and consumer confidence, leadership from the Personal Care Products Council says.
In comments offered at a March 25 public hearing held at FDA’s White Oak campus in Silver Spring, Md., Elizabeth...