FDA OTC labeling studies "procedural, methodological flaws" cited in NDMA letter to OMB.

FDA OTC LABELING STUDIES "PROCEDURAL, METHODOLOGICAL FLAWS" CITED BY NDMA in a June 13 letter to the Office of Management & Budget. The Nonprescription Drug Manufacturers Association asks OMB to withhold approval of FDA's proposed consumer label comprehension studies and to deny the agency's request that the office apply an expedited, or "emergency," review procedure to the research project. FDA's planned labeling studies, involving over 2,000 subjects, are intended to evaluate the format changes proposed by the agency in February and gather information about consumer preferences for label design variations ("The Tan Sheet" May 26, p. 4).

NDMA explains that its "reasons for this request focus both on procedural aspects of FDA's proposed collection activities and on substantive problems with the design of the surveys and the associated questionnaires." The letter elaborates on arguments made by NDMA at a June 9 meeting with OMB.

The association points out that FDA proposed the research nearly three months after the Feb. 27 publication of its proposed rule on OTC labeling changes and "over a year after FDA had received numerous comments through dialogue and a written solicitation" on the subject of OTC label reform ("The Tan Sheet" March 3, pp. 1-9). "Posthoc development of support for the proposed rule is inappropriate," NDMA asserts. "It is also unfair to the outside parties that have acted in good faith to develop comments in 1995 in preparation for the proposed rule and now to respond to FDA's proposal."

"Such research, if it was to have been done at all, should have been done by FDA in 1995 -- not now after the agency's proposal has been published," NDMA argues.

The letter maintains there is "no public health crisis with OTC labels as they are currently formatted and therefore there is no basis for emergency processing" of the surveys. OTC labels "have all the information that is needed for safe and effective use," the association continues. If OMB does not stop FDA's proposed research plan, the association states, "then recognition that there is no need for emergency processing would allow the time needed to develop the kind of quality research that would be meaningful and helpful to OTC label readability," NDMA adds.

The results of the surveys, if they go forward, "will provide no additional support for the finalization of a major rule that will cost the industry between $155 mil. and $400 mil., depending on whether...packaging changes are needed to comply with the rule as proposed, " NDMA states. Nevertheless, industry "favors the rule, despite its potential cost" and "vigorously opposes the proposed surveys as they are flawed and could lead to unnecessary and costly changes."

The surveys, as designed, address "aspects of label readability for which there is wide agreement by experts," NDMA argues. The one outstanding issue on which there is disagreement, whether a minimum 6-point type size should be required, "is not addressed."

NDMA estimates that a 6-point type minimum requirements would "not fit the marketplace for 30% of OTC brand name products and 95% of OTC store brand products." NDMA also notes it is "developing and has under study, a strategy to optimize the use of 6-point type...to reduce the number of products for which the proposal is not fit for the marketplace, thereby reducing the potential for increased implementation cost (i.e., over $400 mil. in packaging changes are needed to resolve the `6-point type size dilemma') and/or the potential for tens of thousands of petitions for exemption from the final rule, which would flood the agency."

The first survey, or "survey A," is designed, among other things, to test consumer understanding of the "dictionary definition" of the term, "health professional." The agency thus "invites a challenge" to its long-standing policy that "health professionals" as cited on OTC labels as sources of drug information includes doctors, pharmacists, dentists, nurses, nurse practitioners and physician's assistants, NDMA states.

However, the association argues that health professional "is a term which is situation-dependent for its definition." For example, to a mother with a question on a children's fever reducer, health professional may mean a triage nurse in a pediatric practice, while to the same mother with a question about a fluoride-containing toothpaste, health professional may mean a dentist." FDA's proposed way of testing consumer understanding of "health professional" is thus "inadequate, will likely lead to less than complete answers, and may mislead any decision by FDA to include or exclude a `health professional' subheading," according to the comments.

Survey "B" is "fundamentally flawed in design and rationale by virtue of its complexity and its intention to use consumer preferences as drivers of key label elements that should rightfully be based on professional decisions," NDMA argues.

FDA proposes to assess whether active ingredients should be first or last, whether warnings should be before or after directions, whether "Medication Facts" should be used as a title to the information panel, and whether thick or thin lines should separate the major headings. Although NDMA previously advocated the placement of directions before warnings, FDA included the reverse order in its proposed rule, NDMA notes. However, after "careful deliberation of this matter with input from health professionals," the association states, "we agree with FDA's proposed order."

Placing warnings before directions is "particularly important in situations where there are contraindications against use of an OTC, such as the possible life-threatening consequences for a person on a monoamine-oxidase inhibitor using a product containing a cough suppressant or nasal decongestant," NDMA notes. The group adds that "common sense should be used to resolve this, not a survey."

If OMB does not choose to act on the "flaws" in FDA's proposed collection activities, NDMA urges the office to recommend that FDA convene a special working group composed of representatives of the interested parties "to work together to develop a research proposal of quality design and with sound questionnaires." If FDA "thinks the research is so important that it must be done to support issuance of a major rule, then it must also be important enough for all interested parties to have the opportunity to comment on the research, both before it is undertaken and after the results are reported," the association maintains.