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Executive Summary

OTC ANTIHISTAMINE "POST-NASAL DRIP" EFFICACY NOT DEMONSTRATED by consumer surveys, FDA said in a recent feedback letter to the Proprietary Association: "The consumer surveys do not demonstrate understanding of the term 'post-nasal drip' or provide a basis for a 'post-nasal drip' indication," FDA OTC Drug Evaluation Division Director William Gilbertson, PharmD, stated. "The division . . . is therefore proposing that indications pertaining to 'post-nasal drip' not be included in the final monograph for OTC antihistamine products." Gilbertson's Dec. 29 letter was in response to P-A's comments on the tentative final monograph for OTC antihistamine products published in the January 15, 1985 Federal Register. P-A had requested that OTC antihistamines be allowed to carry the indication: "Helps (relieve, alleviate, decrease, reduce or dry up) post-nasal drip." P-A had cited two consumer mail panel surveys that identified relief of "post-nasal drip" as an important consideration in choosing OTC sinus remedies. One of the P-A surveys found that 129 (49%) of 263 respondents considered relief of post-nasal drip "important." A survey of hay fever sufferers found that 119 (48%) of 248 respondents felt that treatment of post-nasal drip was important. FDA challenged the appropriateness of using consumer-oriented surveys to determine medical indications. "The submitted consumer surveys were not designed to demonstrate the effectiveness of OTC antihistamine products in relieving the symptom 'post-nasal drip.'" In addition, the feedback letter adds, "the surveys do not define the term 'post-nasal drip' or the ability of the consumer to recognize specific symptoms that would allow the consumer to determine whether he/she is experiencing 'post-nasal drip.'" Therefore, the surveys do not "demonstrate understanding of the term," FDA said. FDA is asking for clinical studies designed "specifically to demonstrate the effectiveness of antihistamines in relieving 'post-nasal drip'" in order for approval of a claim for OTC antihistamine labeling. "Such studies should be designed to evaluate the symptoms of 'post-nasal' drip in terms of specific symptoms that can be recognized by consumers as 'post-nasal drip,'" Gilbertson said. "We are not aware of the agency having approved a 'post-nasal drip' claim in any new drug application for an antihistamine drug product."

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