US FDA Update On OTC Labeling And PDUFA

The AIDS epidemic was a turning point in the US Food and Drug Administration's relationship with industry, Sharon Smith Holston, FDA deputy commissioner for external affairs, told the the US Nonprescription Drug Manufacturers Association's annual research and scientific development conference. It abandoned its arms-length arrangement, setting a pattern for discussion which has helped speed approvals. Now, no new rules or guidelines are issued without consultation or feedback, and the agency uses all available forms of communication, from print to the Internet.

Two major directions in FDA communications policy which will enhance consumer protection and public health are: more communication with industry and regulatory agencies abroad (sharing the regulatory burden helps the FDA deal with its growing workload, which came with no comparable growth in financial resources); and bringing information direct to consumers. Creating a more harmonious atmosphere has also helped raise compliance levels, while closer cooperation with industry stimulates scientific progress and improves public health, she said.

Consumer communication offers the best potential for improving public health, and is done mostly through the label. In making the over-the-counter label as informative and understandable as possible, the FDA is looking closely at NDMA proposals, and it is pleased that some are already incorporated into new product labels. Labels are made more comprehensible and useful by: informative headings and subheadings; uniform type and sizing; adequate spacing and other graphical features; terse, simple text in bullet format; and more emphatic warnings in a standard format and in a prominent place.