NDMA WOULD SIMPLIFY OTC DRUG LABELS

JIM OSTROFF

WASHINGTON (FNS) -- The Nonprescription Drug Manufacturers Association here unveiled a plan to revamp over-the-counter drug labels in a seven-step process it says would make the labels more consumer-friendly.

The proposal, announced last week at an NDMA press briefing, would affect every product in the $14 billion OTC industry.

However, it will go nowhere unless the Food and Drug Administration agrees to implement it. The FDA is expected to decide within several months whether it will adopt the NDMA plan. The association is asking FDA to amend its 1986 "flexibility rule," which mandates that all proposed policy changes undergo formal regulatory proceedings. NDMA is opposed to full regulatory review -- a process in which drug monographs (documents that fully describe a drug, including its purpose for use, contraindications and indications) are evaluated -- because it can last for several years.

NDMA said if FDA adopts its plan, labels would be changed in a more timely manner. James D. Cope, president of Washington-based NDMA, said its proposal -- which received broad support at an FDA hearing in September -- would permit the industry to begin "as soon as we can to redo all labels on all products and to complete the process within three years of the final OK" from the agency.

The NDMA plan amplifies upon the one it unveiled at the September FDA hearing, which sought public comment on ways OTC drug labels can be made easier to read and understand. "With design and format changes and with simpler language," Cope said at a press briefing here last week, "we not only propose to make our labels even easier for consumers to read and understand, but to reduce the number and complexity of the words needed to do this." Association officials emphasized the content of current OTC drug labels in no way poses any public health problems.

NDMA's plan would establish uniform headings for key mandatory labeling information such as "Active Ingredient(s) and Action(s); Use(s), Directions and Warnings." It proposes eliminating the word "Indications" in lieu of the word "For," such as "For the Temporary Relief of."

In addition, it proposes "a standard set of warning subheadings in order to [highlight] contraindications first and in-use precautions second, and break up the often large block of warning language.

It also asked FDA to require a uniform order for all mandatory label information on OTC drugs. This 20-point list includes such descriptors as "Active Ingredient(s), Action(s), Directions, Warnings and Do Not Use Without Asking a Doctor."

The proposal further would require a mandatory minimum type size and require national uniformity in label information for all nonprescription drug products marketed in the United States. It also would retain current FDA warning language, require that the mandatory headings and subheadings be highlighted and that all the label changes take effect within three years after the date FDA approves these revisions.

However, NDMA recommended that pictograms should not be required by the agency for use on OTC drug labels, reasoning that these symbols "are highly susceptible to differing interpretations."