IN RESPONSE:

In 1972, the FDA began a review of over-the-counter drug products to assure their safety and effectiveness for the intended uses. As a result, many reformulations and relabelings of over-the-counter drug products were anticipated, and the agency said that it would not take legal action against over-the-counter drugs if the changes in the formulation or labeling would increase effectiveness without decreasing safety, or vice versa.

In the Federal Register of 27 March 1974 (39 FR 11298), the agency published proposed regulations that required deletion of a trade name where there had been a fundamental change in the indications for use or active ingredients of the drug product. However, that proposal was never finalized, and the agency announced withdrawal of the proposal in the Federal Register of 30 December 1991 (56 FR 67440).

The FDA is aware that manufacturers use the same trade name on reformulated products. The accepted industry procedure is to indicate in the product's labeling that a significant change has occurred, which the manufacturer has done with the new Anusol product.

Over-the-counter drug products for anorectal use were evaluated by an advisory review panel to determine which ingredients are acceptable. The final monograph on over-the-counter anorectal drug products was published in the Federal Register of 3 August 1990 (55 FR 31776).

Phenylephrine hydrochloride is included as a vasoconstrictor in section 346.12(d) and zinc oxide is included both as a protectant in section 346.14(b) (4) and as an astringent in section 346.18(c). Thus, the current Anusol Suppositories formulation contains active ingredients that are in conformance with the monograph.

Although not required by regulation, the product packaging contains the phrase "NEW IMPROVED FORMULA" in two places to alert the consumer to the change in formulation. By placing the warning about heart disease and high blood pressure, and the drug interaction precaution relating to high blood pressure and depression on the product's labeling, the manufacturer has addressed some of Dr. Merikangas' concerns.

The FDA is aware that there is a potential problem with the readability of labels of some over-the-counter drug products, another issue raised by Dr. Merikangas. On 6 March 1991, the FDA published a notice in the Federal Register requesting public comments on the print size and style of labeling for over-the-counter drug products. We received several comments from consumers indicating readability problems. Several other comments pointed out that readability is not only dependent on the size of the print on the labels but also on the style, color, contrast, sharpness of the lettering, use of upper or lower case lettering, the amount of "open space" surrounding the type, and so forth.

Subsequently, the National Drug Manufacturers Association, a trade association of over-the-counter drug manufacturers, established voluntary guidelines for companies to follow.