NIH To Hold Hearing on Request To Produce Generic Version of Abbott Antiretroviral NorvirNIH in May will hold a public hearing to discuss a request to allow the production of a generic version of Abbott Laboratories' antiretroviral drug Norvir, Reuters reports. Essential Inventions, a not-for-profit group run by consumer advocates, has filed a request with HHS for a license to produce a generic version of the drug while it is still under patent, according to Reuters (Reuters, 4/28). 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 (Kaiser Daily HIV/AIDS Report, 4/27). Essential Inventions said that the drug was developed using federal funding and is now being sold at "an unreasonable price," Reuters reports. 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, according to Reuters (Reuters, 4/28). In cases involving drugs that were developed with federal funding -- as Norvir was -- the government reserves the right to demand reasonable prices from the drug maker, although it has never done so. Federal health authorities fear that any effort to control drug prices could discourage drug companies from collaborating on research with federal agencies (Kaiser Daily HIV/AIDS Report, 4/20).
Abbott spokesperson Jennifer Smoter said that the Bayh-Dole Act was meant to be used when the public "did not have access to an invention supported by taxpayer funds," which is not the case with Norvir, according to Reuters. She added, "We make sure people have access" to the drug. Smoter said that Abbott expects to be invited to the public hearing, and the company will send representatives if asked to attend, Reuters reports. Essential Inventions Founder James Love said that he was "delighted" with the administration for scheduling a public hearing on the issue, according to Reuters. He added, "At this point, this is progress." The hearing is scheduled for May 25, Reuters reports (Reuters, 4/28).