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FDA-APPROVED DRUGS CANNOT BE IMPORTED LEGALLY

Executive Summary

FDA-APPROVED DRUGS CANNOT BE IMPORTED LEGALLY from foreign sources, the agency said in a Jan. 9 "Talk Paper." The release was issued to contradict promotions of a book that "seriously misrepresents" the agency's personal importation policy for unapproved drugs. Titled "How to Buy Almost Any Drug Legally Without a Prescription" by James Johnson, PhD, the book claims "to tell people how they can 'legally' import foreign versions of drugs that have been approved in the U.S." The book maintains that people can save money on drugs by importing and avoid going to a doctor for a prescription, the "Talk Paper" states. FDA's import policy allows individuals to bring into the U.S., for their own personal use, small quantities of drugs available overseas, but not approved in this country. The agency explained that these products must meet certain criteria: they must "not pose unreasonable or significant safety risks," their use must "not be commericalized," and they must be "for a serious condition for which there is no satisfactory treatment available in this country." The "Talk Paper" points out that "although the book reprints several recent FDA documents that explain the personal importation policy, the book's authors disregard the section of the policy that limits its application to only unapproved drugs that are not available in this country." Apparently, the agency is looking into several violations of the import policy. The "Talk Paper" notes that "FDA field offices are instructed to recommend that import alerts be issued to automatically detain imported products that appear to violate the personal import policy." One approved drug that is currently imported into the U.S. is aerosolized pentamidine, which is sold in Europe by Rhone-Poulenc. Lyphomed gained FDA approval for aerosolized pentamidine NebuPent for prophylaxis of Pneumocystis carinni pneumonia. An internal memorandum indicates that the company, now owned by Fujisawa, set up a post-marketing study for NebuPent as a marketing tool to regain the market lost to imported pentamidine, which is sold at a much lower price. The People With AIDS Health Group obtained the Nov. 1 memorandum that describes details of the post-marketing study. The memorandum to hospital sales managers states: "The NebuPent Post- Marketing Study Program has been developed to capture business lost to illicit pentamidine in private physician accounts." The memo notes that "the program is intended to be used exclusively for accounts that we have lost to imported pentamidine." The NebuPent program "provides for one free vial of NebuPent for each purchased at $ 99.45," the memo states. "To justisfy the free goods, the physician accounts that are enrolled in the program will be asked to conduct a research project -- 300 mg versus 600 mg once monthly for prophylaxis." The People With AIDS Health Group acts as a "buying club" for AIDS drugs, including pentamidine which it has been importing from Europe since the fall of 1989. The group currently buys pentamidine for $ 46 a vial from Germany. In Germany, the retail price is $ 29 a vial. NebuPent's retail price can be $ 120-200 a vial, or higher, PWA said. NebuPent's wholesale price is $ 99.45 per 300 mg vial. A future importation concern could be AZT manufactured in Canada and imported from the Bahamas or other countries that do not recognize the patent rights of Burroughs Wellcome, developer of AZT (Retrovir). The issue was addressed on ABC's World News Tonight on Jan. 3. According to a transcript of the program, ACIC, a Toronto-based drug company, is manufacturing AZT. According to the news report, another company Apotex, Inc. is purchasing the Canadian-made AZT and is shipping it to other countries. ABC said that Americans could buy the AZT from the Bahamas through the mail for "89 cents per capsule, one-third less than what Burroughs charges." Retrovir sells "for $ 1.20 a capsule." Apotex and another Canadian drug company, Novopharm, are challenging AZT's patent in Canada. The Canadian-made AZT can be ordered through a business called International Pharmacy (Interpharm, Inc.) located in Nassau, in the Bahamas. Interpharm's order form lists 100 capsules of AZT 100 mg for a price of $ 89.00. The generic drug firm Interpharm, Inc. of Plainview, New York, said that it has no relation to the AZT distributing group.
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