Eight Democratic senators on Tuesday sent a letter to NIH Director Elias Zerhouni calling for a Federal Trade Commission representative to speak at a public hearing to discuss a request to allow the production of a generic version of Abbott Laboratories' antiretroviral drug Norvir, the Wall Street Journal reports (Abboud, Wall Street Journal, 5/13). In December 2003, Abbott increased from $54 per month to $265 per month 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 group run by consumer advocates, has said that the drug was developed using federal funding and is now being sold at too high a price. The group has filed a request with HHS for a license to produce a generic version of the drug while it is still under patent, and NIH has scheduled a public hearing on the issue for May 25. According to Essential Inventions, 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, as Norvir was. However, the government has never done so because they fear that any effort to control drug prices could discourage drug companies from collaborating on research with federal agencies (Kaiser Daily HIV/AIDS Report, 4/30). The letter calls for an FTC representative to appear at the hearing to discuss "competitive issues" brought about by Norvir's price increase, according to the Journal. FTC officials declined to comment, the Journal reports.

"Anticompetitive" and "Unreasonable"?
HIV/AIDS advocates have protested at Abbott's offices and its annual meeting and have filed civil lawsuits in state and federal courts over the price increase. In addition, three state attorneys general are investigating the price increase, and FTC has received a complaint claiming that the price increase is "anticompetitive," the Journal reports. The "central issue" to be considered at the hearing is whether the price increase "represent[s] an 'unreasonable' use of the patent that limits public access to the drug," according to the Journal. Jeffrey Leiden, president of Abbott's pharmaceutical products group, said that the price increase "in no way" limits access to Norvir, adding, "We took extraordinary measures to make sure that not a single patient was deprived of the drug." Leiden said that Abbott did not change the price of the drug for public programs subsidizing treatment for low-income people living with HIV/AIDS -- including Medicaid -- and made it easier for uninsured HIV-positive patients to obtain the drug at no cost, the Journal reports. Leiden said that Norvir continues to be the least expensive protease inhibitor on the market, according to the Journal (Wall Street Journal, 5/13).

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