Successful Rx-To-OTC Drug Switching: NDMA

The single word "switch" is used when talking about a drug moving from prescription to over-the-counter status, but there are in fact three different processes, Jack Anastasia, procter & Gamble's director of worldwide regulatory affairs for OTC drugs, and Mark Gelbert, acting director of scientific affairs in Sandoz' consumer drugs division, told the US Nonprescription Drug Manufacturers Association's annual research and scientific developments conference.

Pure switch, pseudo-switch and active switch would be a better description, they said. Pure switches involve the prescription drug, in its original strength and dose, moving to OTC status for its original or a similar indication. A pseudo-switch has the active ingredient from the Rx product being switched at a lower or different dosage, while the active switch has the same ingredient at a lower dose or the same dosage being switched for a new or different indication.

The six steps in a successful switch application, most involving interplay between the sponsor company and the Food and Drug Administration, are: