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Executive Summary

PFIZER's FLUCONAZOLE IS AMONG UNAPPROVED AIDS DRUGS that will be imported by the People with AIDS Health Group (PWA) to treat U.S. patients with AIDS and its opportunistic infections, the New York City-based buyers' group reported in a March 6 press release. The oral antifungal agent, which has shown activity against cryptococcal meningitis, is currently approved in France, England, Denmark and Austria. During the week of Feb. 27, Pfizer filed an NDA in the U.S. for fluconazole, which will be marketed under the Diflucan brand. Pfizer said it has made fluconazole available in the U.S. since the summer of 1987 under a compassionate IND for patients unresponsive to amphotericin B. The company said it is working with FDA to expand the criteria for compassionate use. Pfizer is seeking approval of fluconazole for the prevention and treatment of systemic candidiasis and other fungal infections, and for acute and maintenance therapy against cryptococcal meningitis. In a prepared statement, Pfizer said it believes that "the compassionate use and clinical programs will ensure that patients with life-threatening fungal infections will have access to the drug while it is still under review by FDA." The drug is currently available in the U.K., Ireland, Austria, Denmark, and France, and was recently approved in Switzerland. PWA board member Michael Callen said the PWA Health Group "will consider, on a case-by-case basis, which drugs and substances available in other countries it will help facilitate access to. Issues of toxicity, possible efficacy, quality control, price and general availability are all taken into account in making our determinations." The action, announced at a same-day press conference, is in response to FDA's more lenient position on the importation of unapproved prescription drugs for personal use. The agency spelled out its policy on drug importing for personal use in July 1988. At that time, FDA also noted it was cracking down on at least one firm that had set up an import operation for unapproved AIDS drugs ("The Pink Sheet" Aug. 1, p. 3). Buying group activities, such as PWA, have been limited in the past to the procurement of OTC medications like dextran sulfate. Individuals were required to travel to a foreign country and be treated by a local doctor in order to gain access to prescription drugs. Under the new initiative, PWA Health Group said it will obtain prescription drugs "through various channels," and import them into the U.S. for use by patients with or at risk of AIDS. The group said it will require documentation substantiating that the individual is under a doctor's supervision for a given treatment. FDA has indicated that its chief concern about buying groups is the potential to financially profit from such drug import activities.

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