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Executive Summary

FDA STRENGTHENING ENFORCEMENT POLICY AGAINST PROBLEM IMPORTERS with a revision of agency guidelines on how to deal with foreign companies that repeatedly import products in violation of FDA regulations. The ageny announced the availability of its revised "Priority Enforcement Strategy for Problem Importers" in the Feb. 12 Federal Register. The agency's strategy emphasizes measures typically used against domestic firms engaging in violative importing actions. They include warning letters, reconditioning proposals, recalls, seizure actions, injunctions and citation/prosecution. FDA already has begun actions against several mail-order drug firms that have been promoting a variety of foreign versions, some counterfeit, of U.S. brandname and generic pharmaceutical products. In a Jan. 30 "Talk Paper," the agency listed six foreign firms that have been put on import alert for automatic detention because of importation of unapproved products ("The Pink Sheet" Feb. 10, T&G-13). A warning letter was sent Jan. 28 to a seventh firm, Apotex, which manufactures products promoted by one of the companies on the import alert list. The Canadian firm Apotex supplies drugs to Bahamas-based InterPharm, which has touted 60% savings on major brandname drugs in its promotional materials. FDA told Apotex that its drugs, mail-ordered direct to U.S. consumers, and the company's promotional labeling, advertisements and solicitations are in "serious violation" of the FD&C Act and "falsely represent the legitimacy of these activities." FDA told Apotex that it is notifying Canadian regulatory officials of the company's violative practices and that the agency will automatically detain any products the firm attempts to import into the U.S. Apotex' president is Bernard Sherman, who is also the chairman of the U.S. generic drug firm Barr Labs. Apotex, which has challenged Burroughs Wellcome's AZT patent in Canada, had been exporting AZT to InterPharm ("The Pink Sheet" April 22, T&G-4) for import into the U.S. The heightened enforcement activity in drug imports is apparently due to an increase in the number of foreign firms intent on taking advantage of U.S. consumers' perception that prescription drug prices are exhorbitantly high and flooding the market with promotional literature offering the same drugs at deep discounts. FDA reportedly received some prodding in the import enforcement area through congressional inquiries. The FDA enforcement document informs agency import program managers that priority attention should be given to firms "with a history of any of the following actions": distribution of imported products prior to a May Proceed or Release Notice, or after Refusal of Admission; repeated importation of violative products; falsification of documents at the time of entry or misdeclaring products at the time of entry; failing to recall or redeliver to the U.S. Customs Service at its request a refused product; or introducing or delivering a product that is misbranded, adulterated or a new drug without an approved NDA.

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