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.
