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Executive Summary

Sen. Hatch (R-Utah) is counting on a three-tier feature for categorizing importing countries to enhance the appeal of his drug export bill. Speaking at a Sept. 19 meeting of the Regulatory Affairs Professionals Society (RAPS), Hatch said the bill, which is still in draft form, will be introduced "soon." The three-tier system is designed to prevent the shipping of drugs to countries that lack regulatory mechanisms sufficient to ensure their safe handling and use, the senator explained. Except for banned products, which cannot be exported in any circumstances under the proposal, "drugs which have not yet been approved by FDA could be exported depending on the level of competence of the importing country's regulatory system," Hatch said. The Senate Labor & Human Resources Cmte. staff reportedly completed the draft during the week of Sept. 16. Introduction was said to be awaiting the review of Sen. Kennedy (D-Mass.), the cmte.'s ranking minority member, so that he could sign on as a co-sponsor. "Unapproved drugs could be shipped to those countries with adequate, respected systems if import is legal under their laws. These are first-tier countries," Hatch explained. "The second-tier countries are those with systems not qualifying as first-tier, but which are capable of ensuring that information provided to physicians, pharmacists, and patients is consistent with the drug's labeling. Export to second-tier countries would be allowed only if a first-tier nation had approved the drug." "All other nations fall into the third-tier, to which export would not be authorized, except for so-called 'tropical disease' drugs," Hatch continued. Other provisions have been added to limit exports to pharmaceuticals in which mfrs. have "strong confidence," the senator pointed out. "There are additional provisions to give mfrs. a strong incentive to export responsibly only drugs in which they have full confidence, and the prosposal would ensure that exported drugs are subject to testing, labeling, and quality control procedures which don't govern the same drugs purchased now from another foreign source," Hatch said. "So contrasted with present law, my proposal would be a step forward in health terms."

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