NIH Hears ‘Sharply Differing Views’ on Request To Produce Generic Version of Abbott Antiretroviral Norvir

AIDS advocates, pharmaceutical company representatives and others on Tuesday at an NIH hearing offered "sharply different views" on Essential Inventions' request to produce a generic version of Abbott Laboratories' antiretroviral drug Norvir, the AP/Las Vegas Sun reports (Schmid, AP/Las Vegas Sun, 5/25). In December 2003, Abbott increased by about 400% the per-patient wholesale price of Norvir, which is known generically as ritonavir. Norvir is used primarily as a booster for other protease inhibitors, such as Bristol-Myers Squibb's Reyataz and Merck's Crixivan. Essential Inventions, a not-for-profit organization run by consumer advocates, last month filed a request with HHS for a license to produce a generic version of the drug while it is still under patent, saying that the drug was developed using federal funding and is being sold at an unreasonably high price. According to the group, under the 1980 Bayh-Dole Act, the HHS secretary has the authority to grant licenses to other manufacturers to produce patented medicines that were developed using federal funding. In cases involving drugs that were developed with federal funding, the government reserves the right to demand reasonable prices from the drug maker (Kaiser Daily HIV/AIDS Report, 4/30). Abbott received a $3.47 million NIH grant in 1988 for early research on protease inhibitors (Richwine, Reuters, 5/25). Although the grant did not lead directly to Norvir, the team of researchers that was formed under the NIH grant eventually developed the drug, according to the Washington Post (Brown, Washington Post, 5/26). The company says that the grant represents less than 1% of the more than $300 million spent to develop Norvir (Reuters, 5/25).

Testimony
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 Inventions 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).

Ruling
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 Inventions' 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).