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Executive Summary

Rep. Dingell (D-Mich.) is taking a wait and see attitude toward FDA's proposed anti-drug diversion program of detaining drugs to American ports until adequate documentation for each shipment is produced, the Michigan Demo said in an Aug. 29 letter to FDA Com. Young. Dingell, Chairman of the House Energy & Commerce/Oversight & Investigations Subcmte., said the subcmte. is "prepared to withhold judgment on the effectiveness of the alternative system of control proposed by FDA." However, Dingell told Young that he is "disappointed" that FDA "declined to order the testing" of all pharmaceutical shipments entering U.S. ports designated as "American goods returned." The agency informed the congressman in an Aug. 21 letter that, under a new directive, FDA inspectors "will automatically detain all drugs that are American goods returned until adequate documentation is provided by the importer." Specifically, the agency said, the new system will "assure that the shipment's chain of custody can be documented back to the orginal mfr., that the drug's expiration date has not been passed, and that the reason for the goods' return is not indicative of adulteration or other" FD&C Act violations Dingell had asked FDA and the U.S. Customs Service to implement a policy of detaining all shipments of returned goods until they can be tested. The request followed discovery that counterfeit versions of Searle's Ovulen 21 made in South America entered the U.S. labeled as "American goods returned" ("The Pink Sheet" Aug. 12, p. 3) Responding to Dingell's request and explaining FDA's directive, Young wrote: "Resource limitations prevent us from sampling every returned drug." However, he said, "we will continue our program of routinely sampling and analyzing certain drug imports, regardless of country of origin." In an Aug. 30 press release, Dingell said: "Com. Young has promised total vigilance but stopped short of committing to test these high-risk substances." On the other hand, the congressman praised Customs Service Com. William von Raab for mobilizing Customs "to detain those pharmaceutical imports which pose the greatest threat to the health and safety of American consumers." In light of "the meager resources doled out to the Customs Service by the administration, it is heartening to see that agency react so quickly to this growing threat to the public health," Dingell remarked. FDA notified the Customs Service of its new procedures on Aug. 14, when "FDA's top regulatory and field officials met with their counterpart officials at customs," Young said. In an Aug. 13 letter to Dingell, Com. William von Raab said Customs would comply fully with the subcmte. request. "All pharmaceuticals entered with a claim of American origin will be denied release pending FDA action," von Raab declared, and "import specialists have been directed to initiate a careful screening of entry summary packages involving pharmaceuticals, including all returned American goods claims." Further, the Customs commissioner continued, "risk alerts" for the firms named in the subcmte.'s drug diversion report as having participated in the documented diversion schemes "have been entered into our data base, and all future importations wil be thoroughly screened."

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