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FDA HAS ROOM FOR INTERPRETATION AND FLEXIBILITY IN DEFINING "OTCness" UNDER CURRENT STATUTES, WEINTRAUB SAYS; ESCHEWS "RECIPES," RIGID RULES FOR SWITCHES

Executive Summary

FDA's statutory language governing OTCs provides "a lot of room for interpretation and flexibility," FDA consultant Michael Weintraub, MD, told the agency's new OTC Drugs Advisory Committee at its first meeting on Dec. 16. In a presentation entitled "Reflections on OTCness," Weintraub said that OTC labeling and how the agency interprets "collateral measures" in granting OTC status give FDA a "fair amount of flexibility and creativity." He noted that the agency has a number of options when considering collateral measures that could be required for a switch product, such as "diagnostic levers, dose adjustment or careful following of the monographs." Weintraub is the de facto director of the new OTC Office of Drug Evaluation, although he has not yet been officially named to that position. "This is a time, I believe, of changes in the boundaries, the notions, the definitions about what is really appropriate, what is 'OTCness' within the parameters of the statute and regulations that have grown up around the statute," Weintraub declared. Weintraub cautioned that issues of "self-diagnosis, the self- selection of therapeutic agents and self-monitoring for outcome are important concepts [and] aspects of OTCness." He pointed out that "there are, of course, risks...when we put the consumer...at the center of the diagnostic and medication selection and the monitoring and follow-up process." Those risks, he suggested, include "the possibility of making an incorrect diagnosis, treating a condition that isn't there, or perhaps missing an important serious illness and treating it with an OTC medication." He indicated that adequate labeling still may not prevent situations where consumers may take a contraindicated medication or may not follow "label directions properly in terms of the dose, the duration of treatment and...the indication itself." FDAers will continue "to ask ourselves about the benefit for individuals or for society as a whole for having a medication on the OTC market and whether that benefit exceeds any risk of having that medication available over the counter," Weintraub said. However, Weintraub observed that "what we're seeing now is that the kinds of medication being considered for switches has really been evolving and changing [and] the indications for which those medications are to be used is also changing." He noted that FDA's views "of what is an appropriate OTC dose versus the prescription dose, what is the appropriate duration of use... the need for external monitoring, are all changing every day." Weintraub framed his comments in terms of the definition of OTCness and methods for determining appropriate OTC status. He suggested that the "definitional aspect of what characterizes appropriate OTC medications and uses" is changing due to a number of important societal trends, including a more knowledgeable patient population, an increased willingness by individuals "to take more responsibility for their own health care and health," and what he called "systemic changes" in the medical environment. "Everybody always speaks about the financial aspects that have changed so dramatically, and that is quite true," Weintraub said. "I think that the possibility of decreasing costs to the entire medical system [is] made feasible by OTC medications." In addition, he asserted that "the role of the physician [is] changing to one which I believe is increasingly evolving to that of a teacher and technical advisor as opposed to the parental figure [that tells] people what to do." As a result, he predicted "the whole medical system is going to reevaluate what OTCness really is." Methodological changes in clinical trials also are having an impact on the OTC environment, Weintraub suggested. He noted that "it's not easy to study an OTC drug...the indications tend to be more subtle; in some cases, the dose has been lowered, thereby decreasing a difference you might be able to show between an active ingredient and a placebo; and chances for spontaneous improvement are greater." OTC clinical studies, he said, are "much more difficult in some ways to carry out and, therefore, they're more difficult to interpret on our side as well." However, he added "there have been a number of important methodologic changes that have enhanced OTCness and altered our definition of OTCness." He pointed out that more companies are conducting "user studies" that are designed to study OTCs the way the products are used in the marketplace. He also cited "naturalistic" trials that include less investigator intervention and follow-up, and that depend on study participants for a greater degree of self- monitoring. He suggested that such trials may be "extremely helpful in ascertaining whether or not an OTC drug works." Weintraub said he is "particularly struck by the creativity illustrated by [FDA's] Pilot Drug [Evaluation Staff] in dealing with the manufacturers of some of the nonsteroidals and other medications that fall under their purview." In addition, FDA is seeing improvements in its "ability to assess epidemiologic and other sorts of information that go into an OTC application," Weintraub said. "This might include what's happening in other countries, what's happening...in Canada, for example, [and] what's happening in the [European Economic Community] to medications that might be available OTC...and considered for OTC status here in the U.S." Weintraub also reiterated his three general principles for Rx- to-OTC switches -- simplicity, consistency and safety -- which were first outlined in a presentation in September at a Nonprescription Drug Manufacturers Association forum ("The Pink Sheet" Sept. 21, p. 9). Under those principles, Weintraub elaborated, a good switch candidate: (1) "shouldn't have complex pharmacokinetics; (2) it "should have a predictable, reliable time course of action; and (3) should have a "margin of safety and overdose characteristics [that are] acceptable and appropriate for OTC use." FDA is not expecting the panel to provide "lists of characteristics", "recipes", "decision trees" or "any of those rigid ways of helping us make judgments" on switches, Weintraub added. "I think making rules might block creativity and that creativity is desirable," he said. "What we're really looking for is your best feelings to guide us, because I think it's clear ...that many of the switches have to be handled on a case-by-case judgment basis." He suggested that OTC office and the advisory committee "together...may be able to design some general parameters of OTCness...that can allow for the special cases." In a welcoming address to the new advisory committee, FDA Commissioner Kessler echoed some of Weintraub's sentiments and called the inaugural meeting of the committee "a sweet moment for a lot of people." Kessler pointed out that with the monograph review process drawing to a close 20 years after the start of the program, FDA is now "at a crossroads." He said that FDA still has "a little work to do because we are at a time when we need to go beyond the drug monographs into an era where I think the public will be increasingly served by these kinds of medicines." Kessler explained that the establishment of the new OTC office and the advisory committee reflect "increasing recognition on [the Center for Drug Evaluation and Research's] part of the importance of these products in the overall health care delivery system." The commissioner noted that OTC products "are a very important part" of the ongoing health care debate. Americans are taking more responsibility for their health care and "want...adequate and accurate information about the products they use," he stated. Kessler directed the committee "to speak your mind" and "don't tell us what we want to hear....You are here because of your expertise."

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