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U.S. sets hearing on Abbott AIDS drug license
  WASHINGTON (Reuters) - The National Institutes of Health will hold a public hearing next month on a request to allow cheaper, generic copies of an Abbott Laboratories Inc. AIDS drug, the U.S. government announced Wednesday.
Essential Inventions Inc., a nonprofit firm run by consumer activists, has asked the Department of Health and Human Services for a license to produce copies of the drug, Norvir, while it is still under patent.
Norvir was developed with support from taxpayer funds and now is being sold at an unreasonable price, the activists argue.
Last December, Abbott raised the price for 100-milligram capsules of Norvir to $8.57 from $1.71--a 400 percent jump.
The company says the price hike was long overdue and was necessary to help fund future drug development.
Norvir is a protease inhibitor used to fight HIV that causes AIDS. It is unique in its class because it can boost the effectiveness of other AIDS medicines.
Essential Inventions says the 1980 Bayh-Dole Act gives the health secretary power to grant licenses to other producers of patented medicines developed with support from taxpayers.
Abbott spokeswoman Jennifer Smoter said the Bayh-Dole Act was intended for use when the public did not have access to an invention supported by taxpayer funds. That is not the case with Norvir, she said.
"We make sure people have access" to Norvir, she said.
The NIH, in a notice published Wednesday, said it would hold a public meeting May 25 for invited speakers to give input.
Abbott expects to be invited and, if so, will send representatives, Smoter said.
James Love, founder of Essential Inventions, said he was delighted the Bush administration was granting a public hearing on the licensing issue. The company requested the license in January.
"At this point, this is progress," he said.

US warns Novartis over hypertension drug promotion
Last Updated: 2004-04-29 13:44:16 -0400 (Reuters Health)
WASHINGTON (Reuters) - Promotional material for Novartis AG's hypertension drug Diovan contain unapproved claims that it helps diabetics maintain proper kidney function, according to a regulatory letter released on Thursday
The U.S. Food and Drug Administration said Novartis distributed sales aids stating the drug could ease symptoms of kidney problems known as diabetic nephropathy. The study cited in the material shows no clinical benefits, the FDA said.
"Diovan has not been shown to be effective in the treatment of any condition related to diabetes," the letter said.
The agency said Novartis has made similar claims in past promotions, including a 1999 brochure stating Diovan aided congestive heart failure and other conditions.
"The sales aid, like other promotional materials Novartis has disseminated in the past, encourages use of Diovan in conditions for which the FDA has not reviewed safety and effectiveness data," the letter said.
The letter, dated April 21, was posted on the agency's Web site Thursday.
Novartis must stop circulating the Diovan materials and make plans to redistribute accurate information to those who have already received it, the FDA said.
Anna Frable, spokeswoman for the Swiss drug maker, said the company was reviewing the letter and would respond to the FDA by the May 5 deadline.
"We did receive the letter, and we take it seriously," she said.
The FDA sends dozens of warning letters each year. In most cases, the issues raised are resolved without further regulatory action. If the violations cited are not corrected, the FDA can seek a seizure, injunction or other penalty.


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