As previously mentioned, Pharmaceutical Research and Manufacturers of America (PhRMA) released a study concluding that authorized generic drugs lead to lower drug prices for consumers.

 The Generic Pharmaceutical Association (GPhA) has replied:

The Generic Pharmaceutical Association (GPhA) believes that the press release and study unveiled by PhRMA regarding its assessment of the marketing of authorized generics misrepresents the real issues related to this practice. It is understandable that the public and the media would interpret this analysis to reflect consumer pricing. Given that this data represents pharmaceutical distribution data – not retail consumer data – the result is an inaccurate implication that consumers will realize savings from authorized generics. As other loopholes in the Hatch-Waxman Act have been closed, brand pharmaceutical companies have turned to the use of authorized generics to create a chilling effect on generic companies pursuing future patent challenges. Under the Hatch-Waxman legislation, Congress created the patent challenge process to provide the necessary checks and balances to the brand-generic patent system. Authorized generics will lead to delayed generic competition and a substantial reduction in savings for all consumers and America’s health care system. Authorized generics are nothing more than brand pharmaceutical products masquerading as generics. Authorized generics, when the brand company introduces or licenses a “generic” version of its product, compete with the true generic during the 180-day exclusivity period, following a successful patent challenge by a generic manufacturer. This practice has only appeared over the past several years, in part as a result of reforms under MMA that closed loopholes that delayed generic competition. Its only intent is to manipulate the market in a manner that interferes with competition from the true generic product following a successful patent challenge.

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