May 26, 2004
Former Sen. Birch Bayh (D-Ind.), who co-wrote the Bayh-Dole Act, said it was not intended to be used by the government to set prices for drugs but to prevent a company from licensing a product and then not developing it in an effort to protect another product already on the market (AP/Las Vegas Sun, 5/25). "It would be the ultimate folly to march in and alleviate the problem ... and in doing so dampen the ingenuity and entrepreneurial skill necessary to develop a permanent cure for AIDS," Bayh said (Heil, CongressDaily, 5/25). Abbott representatives said that the act was intended for use only when the public does not have access to an invention developed with government funding (Reuters, 5/25). Jeffrey Leiden, president of Abbott's pharmaceutical products group, said that is not the case with Norvir, which the company makes "widely available" at no cost or at reduced prices for low-income patients, according to Congress Daily (CongressDaily, 5/25). However, Robert Huff of the New York City-based Gay Men's Health Crisis said that Abbott raised Norvir's price in an effort to increase the total cost of using other companies' drugs that need to be used in combination with Norvir (AP/Washington Times, 5/26). "It is not reasonable to charge ... more just because [Norvir] is used with a competitor's protease inhibitor," Essential Innovations President James Love said, adding, "These acts are not reasonable. They are outrageous pricing abuses" (Japsen, Chicago Tribune, 5/26). Huff also said that the price increase will "inhibit innovation, restrict research, limit medical options and hurt people with HIV" (AP/Las Vegas Sun, 5/25).
Mark Rohrbaugh, director of the NIH Office of Technology Transfer, and Bonny Harbinger, deputy director of the office, listened to the testimony and will report to NIH Director Elias Zerhouni, who will make the final decision on the request, the AP/Washington Times (AP/Washington Times, 5/26). Although NIH is not required to respond within a specific time period, Rohrbaugh said the agency will try to make a decision "as soon as possible," according to the Indianapolis Star (Groppe, Indianapolis Star, 5/26). If NIH rules in favor of Essential Innovations' request, it could be "several years" before a generic version of Norvir reaches the market, NIH officials said, according to the Chicago Tribune. In that case, Abbott would have the opportunity to appeal the decision, the Tribune reports (Chicago Tribune, 5/26).
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