With Limits Of OTC Drug Fact Label ‘Simple Boxes,' Complicated Conditions Remain Rx-Only In US

Merck & Co.'s three lovastatin switch attempts showed "it would be essentially impossible to present what they needed just within the confines of those simple boxes,” says Pegasus Research CEO Clark Richardson. Two decades after DFL launched, FDA, labeling experts and other industry stakeholders recognize its limits and have more consumer comprehension study data to guide decisions on what to include as well how to format an OTC label.

Merck & Co.'s modifications to the DFL for its proposed OTC switch of Mevacor in 2007 didn't convince FDA to approve what would have been the first nonprescription drug indicated for a chronic condition. • Source: Pegasus Research/FDA webinar

The futility of using OTC Drug Facts labels for products indicated to treat conditions more complicated than a cold or heartburn, headaches or allergies was apparent less than 10 years after the format was launched.

That was when Merck & Co., Inc. in 2007 made its third and final unsuccessful attempt to switch a version of the cholesterol drug Mevacor (lovastatin/20 mg), says labeling...

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