NIH May Allow License for Generic Manufacture of HIV/AIDS Drugs
NIH on Tuesday is scheduled to hold a public hearing to consider a request to grant a license for the generic manufacture of the antiretroviral drug Norvir following Abbott Laboratories' decision to increase the drug's price by 400%, the Wall Street Journal reports (Abboud, Wall Street Journal, 5/24). 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. 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 it fears that any effort to control drug prices could discourage drug companies from collaborating on research with federal agencies (California Healthline, 4/20).
NIH will consider whether the government should use the law to "prevent companies from charging whatever they want" for drugs developed in part with federal funding, the Journal reports. NIH also will consider whether the price increase represents an "unreasonable" use of the company's patent that could limit patient access to the drug, according to the Journal. John Erickson, a former Abbott scientist involved in Norvir's development, is expected to urge NIH to act to lower the drug's price. However, former Sen. Birch Bayh (D-Ind.), co-author of the Bayh-Dole Act, is expected to tell NIH that the law was never intended help "dictate" prices, according to the Journal. An Abbott representative is expected to tell NIH that allowing generic licenses for Norvir could prompt companies to turn down federal funding, which could "crimp innovation," the Journal reports. Abbott says that although Norvir was developed using NIH grants totaling $3.47 million, the company has spent more than $300 million on clinical trials and other expenses to bring the drug to market, according to the Journal (Wall Street Journal, 5/24).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.