San José, Costa Rica, since 1956

Federation Campaigns Against Generic Drugs

IN a subtle break from its message last year, the Central American Federation of Pharmaceutical Laboratories (FEDEFARMA) is pushing a pro-name-brand drug campaign that calls into question the quality of generic drugs.Last year, then-president of FEDEFARMA, Rodolfo Lambour, stressed that generic drugs are not inferior, saying, “We have nothing against the concept of generic medicine,” and that they are legitimate, less-costly alternatives when tested properly (TT, Oct. 22, 2004).Now, the federation’s campaign in Costa Rica and Guatemala frames name brand drugs as safer and higher-quality.“The goal of this campaign is to let consumers know what is implied in the quality of a pharmaceutical product and what risks are associated with the purchase of a product that has not demonstrated its quality,” current federation president Christian Naumann said.FEDEFARMA, which represents multinational drug companies including Bayer, Pfizer and Bristol-Meyers Squibb, most of which produce original – not generic – drugs, launched its campaign Sept. 7, and revealed its plans to wire service EFE yesterday.“In our countries, unfortunately, to make it on the health registry, a generic pharmaceutical product is not required to verify its quality or faithfulness to the design of the original,” Naumann said.“Our authorities do not demand studies of bioequivalency or bioavailability.”Bioavailability refers to the amount of the active ingredient in any formula and how it disperses itself in the body, and bioequivalency refers to the proof that the generic product is the same as the original in terms of its effect on the body and its dosage.Some countries have moved forward with proper testing laws, Naumann said, including Costa Rica, which established a regulation that will take effect in February. One drawback to requiring such tests of generic drugs is that it could raise the cost to the consumer. The alternative, however, is uncertainty, at best, and death at worst. Last year a generic blood anti-coagulant called Warfarin was the suspected culprit in the deaths of three patients with mechanical heart valves (TT, Oct. 22, 2004).

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