OTC Producers View FDA Label Moves

The US Nonprescription drug Manufacturers Association plans to have as much input into the writing of regulations on over-the-counter drug labels as the Food and Drug Administration will allow (Marketletter June 12), an NDMA spokesman has told the Marketletter. The organization is already talking to the FDA about what should and should not be included, he said.

The NDMA started its own label readability campaign four years ago. only the FDA can approve changes to simplify and make language on labels more understandable, said the spokesman, but he added that the NDMA disputes the FDA's suggestion that active ingredients be put on the front panel. This data, and warnings, belong on the back panel, he told the Marketletter, pointing out that crowding the principal display panel both confuses the consumer and takes away a primary marketing tool.

Switching "A Priority" Meantime, FDA Deputy Commissioner William Schultz has said that the agency is giving priority attention to requests for switching prescription drugs to over-the-counter status. Speaking at a Food and Drug Law Institute meeting this month, he added that improving OTC labeling was a second priority.