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Executive Summary

FDA DRUG IMPORT DETENTIONS ARE ALREADY EQUAL TO 50% OF 1991 TOTAL in the first quarter of fiscal 1992 (ended Dec. 31) alone, FDA Commissioner Kessler reported in a March 30 speech to the National Food Processors Association in Washington, D.C. Since the beginning of the first quarter, agency officials have detained more than 13,000 violative shipments. Assuming drugs and biologics comprise the same percentage of total shipments as last year, Kessler's 50% figure would include approximately 1,800 drug and biologic shipments detained during the three month period October through December. FDA indicated its plans to strengthen import detention and seizure policy in the previously released "Priority Enforcement Strategy for Problem Importers" ("The Pink Sheet" Feb. 17, T&G-6). In 1991, FDA detained over 27,000 total shipments, of which 77% were food items. The remaining 6,000-plus detained shipments contained drugs, biologics, medical devices and radiological health products, Kessler said. Of those, FDA said 3,725 drug and biologic shipments were detained. Although FDA analyzes less than 4% of the 1.5 mil. entries reviewed by its district offices each year and visually examines another 90,000 products, Kessler maintained that "examinations are so well targeted that about half of them discover violations. That's a very high proportion." The commissioner noted that imported products of 10 drug firms and 30 medical device manufacturers have been added to FDA's automatic detentions list as a result of inspections of manufacturing facilities abroad. In addition, the agency has issued warning letters to seven foreign firms for continued violative activities related to mail-order drugs for a variety of diseases ("The Pink Sheet" Feb. 10, T&G-13). Kessler said of the warning letters that "more are on the way." This month, FDA is expected to begin a pilot program of its computerized Import Support and Information System (ISIS) in Seattle. "ISIS will help us cope with the increased imports in the future by keeping us abreast of all [in]coming shipments and their destinations," Kessler said. Following a 90-day trial period, ISIS will be tested in the Nogales, Ariz. truck port; then the system will undergo a six-month evaluation by the agency. ISIS allows brokers to enter information about their incoming shipments, which is then transmitted through U.S. Customs Service computers to FDA headquarters and distributed to the agency's six regional centers. Until now, FDA has only been able to track those items that have been examined or sampled. To further support heightened import enforcement, the commissioner has promoted Import Operations and Policy Branch from a branch to division. Former branch director Mary Ayling will serve as acting director of the division until the position is advertised. As part of its general emphasis on increased enforcement activity, FDA has strengthened its ties with state U.S. Attorneys General offices around the country. In a March 31 speech to the National Association of Attorneys General, Kessler said that FDA, in conjunction with the national organization, has set up a working group "to exchange information of possible health fraud targets and then to jointly pursue these targets for regulatory action." Recent actions coordinated by FDA and state attorneys general include a 198-count indictment in San Diego against an import ring peddling so-called "fountain of youth" drugs ("The Pink Sheet" March 23, T&G-13). Additionally, on March 30, with the assistance of the Florida U.S. Attorney General, FDA seized 26 vials of diphtheria/tetanus/pertussis vaccine from a Sanford, Fla. pediatrician's office. The product was labeled as being manufactured by the Canadian firm Connaught Labs Ltd., which is not licensed to distribute DTP in the U.S. In a March 27 "Talk Paper," FDA said it initiated the seizure action following a report by Connaught's U.S. subsidiary that sales reps had spotted the unlicensed product at the pediatric clinic.

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