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Executive Summary

Boehringer Ingelheim has officially restarted the process to move Alupent MDI (metaproterenol metered dose inhaler) to OTC status. In June, the firm filed a supplemental NDA to switch the bronchodilator from Rx-to-OTC. The supplemental NDA contains no new studies, Boehringer said. However, the firm noted that before filing the NDA it discussed a number of issues relating to the proposed Rx-to-OTC switch with professional groups, including the American College of Allergists and the American College of Allergy & Immunology. In April 1984, FDA told Boehringer that a supplemental NDA for the switch would be accepted, but the agency advised the firm to consult with medical groups to gain their support for the move. However, the company said that no group has officially endorsed the Rx-to-OTC switch proposal. Opposition from medical specialists was the main reason FDA rescinded its initial 1982 decision to allow OTC marketing of the drug. Among the issues which Boehringer discussed with the professional groups was the concept of pharmacy only sales of the product for a limited transition period after the drug officially becomes an OTC again. The Natl. Assn. of Retail Druggists (NARD)recently took note of Boehringer s metaproterenol NDA filing in a letter to FDA Com. Young urging that the drug be moved to OTC but reserved for sale by pharmacists only for an unspecified length of time. In an Aug. 13 letter, NARD said it had "been informed" that Boehringer's application requested that Alupent "be permitted to be sold on a non-Rx basis but available for an interim transitional period only from licensed pharmacists," NARD Exec VP Charles West said the assn. "is pleased that Boehringer Ingelheim has recognized the key role played by the pharmacist in counseling consumers regarding drugs switched from Rx to non-Rx status." The company said, however, that it has not asked for pharmacist-only dispensing of Alupent. "Alupent MDI should be available only directly from a pharmacist and not simply available in a pharmacy," West said. "Furthermore, this interim pharmacist counseling period should last only as long as necessary for the agency to be assured that consumers are educated by pharmacist counseling in the proper use of Alupent MDI." He asserted that FDA "should not limit this approval for Alupent MDI to any specified time period, as any such time would be arbitrary." NARD for several years has been seeking a third class of drugs for pharmacy-only distribution. Most recently the assn. tried to limit the OTC availability of ibuprofen for an interim transitional period to pharmacists only. In denying NARD's petition concerning ibuprofen, FDA Com. Young stated that the agency "has continued to conclude that limiting certain drugs to sale-by-pharmacy only is unnecessary because a public health need for such a limitation has not been demonstrated ("The Pink Sheet" Dec. 10, 1984, p. 12).

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