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Codacons: "Melatonin becomes a drug... and prices triple"

(AGI) - New York, April 16. – For decades, pharmaceutical companies in the United States have exploited a variety of tactics aimed at preventing the production and distribution of low-cost copies of their drugs in the market. Now the Federal Trade Commission deems illegal one of the most 'widespread strategies that is based on a creative interpretation of the laws on the safety of illegal drugs. The judgment, described by the New York Times, is based on a recent court case involving the pharmaceutical company Actelion.
The new anti-generics under accusation approach is simple. Brand-name drug makers refuse to sell their products to generic companies who need to analyze them to create their own low-cost versions.
Traditionally, manufacturers of generic brands buy samples from wholesalers but, for safety reasons, an increasing number of medicines are marketed with considerable restrictions, forcing generic manufacturers to ask for samples from the companies manufacturing branded medicines which, in most cases, they refuse, arguing that in this way they protect themselves and patients from potential misuse of the products. For their part, however, the manufacturers of generic drugs argue that the ploy limits access to low-cost drugs and that the companies that most aggressively adopt this obstructionist strategy are those whose drugs are nearing patent expiry. As is the case of Actelion, a Swiss company, which is withholding samples of its flagship product: the Tracleer which treats a lung disease and whose patent will expire in 2015.
The problem stems from a 2007 law that allowed the Food and Drug Administration to require detailed safety programs for drugs with serious side effects or potentially at risk of abuse. In many cases, these programs simply direct companies to educate doctors and patients about the risks. But in other cases they require distribution to be limited to licensed pharmacists and healthcare professionals, which paves the way for refusing to distribute samples for generic manufacturing. (AGI).





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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco