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Executive Summary

FDA MAIL IMPORT POLICY FOR UNAPPROVED DRUGS does not require the products to be approved in the country of origin, FDA told Rep. Dingell (D-Mich.) in an Aug. 19 letter. Noting that "in most instances" FDA would expect the drug to be approved in the exporting country, the agency explained, however, that "there could be instances where the product would be experimental in the country of origin and only available from a clinic." FDA's policy explanation to Dingell appears, on one level, to contrast to its previous decision to prohibit importation of dextran sulfate from Polydex in Canada. The agency reportedly considered the drug's unapproved status in Canada when making that decision. However, the primary reason for the Polydex import alert presumably was tied to the company's aggressive promotion of the unapproved drug ("The Pink Sheet" Aug. 8, T&G-3). FDA's letter to Dingell responds to a series of questions the House Commerce/Oversight Subcommittee chairman had asked FDA about the import policy ("The Pink Sheet" Aug. 15, P. 13). Dingell's Aug. 8 letter specifically questioned how the agency would set an "unreasonable risk" standard for prohibiting some imports. Responding, FDA said: "Products for which an unreasonable risk exists are often the subject of an import alert, which prohibits their importation into the United States. These import alerts are issued after a scientific review by FDA officials within the various reviewing divisions . . . This review is based on any specific data available to the agency as well as data available in the medical literature." FDA also noted that it will "continue to detain fraudulent products for which no scientific rationale exists." FDA emphasized to Dingell that the agency has, for a number of years permitted the import of small quantities of unapproved drugs and that the guidance does not reflect new policy. For example, in response to Dingell's question about whether any other government agencies were contacted before FDA issued the guidance, the agency stated: "No . . . We were not formulating brand new policy; rather, we were simply providing consistent instructions to our field offices on this issue. Therefore, we did not feel it was necessary to seek counsel and advice outside the agency." FDA gave a similar response to Dingell's questions about the potential effects on the clinical trial system. Noting that mail imports were previously permitted on an ad hoc basis, FDA said: "We, therefore, do not believe that the impact of this pilot guidance on the clinical testing of drugs will differ significantly from our past experiences in this area." FDA noted that the pilot guidance would allow the import of unapproved drugs that are under investigation, either in clinical trials or through a Treatment IND, in the U.S. FDA's letter also stresses that the guidance is being implemented on a "pilot basis" and may be subject to change or cancellation. "We will monitor the situation very closely and are prepared to take appropriate action if necessary," the agency said.

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