Tuesday, October 12, 2004

Drug test at Stanford under "Best Pharmaceuticals for Children Act"

The Hatch-Waxman Act, as amended, provides for a patent extension for pediatric testing. In the case of drugs no longer under patent protection, the federal government can provide contracts for testing of unpatented drugs through the National Institute of Child Health and Human Development of the National Institutes of Health (NIH).

--> from the Stanford University Medical Center

In 2002, Congress passed the Best Pharmaceuticals for Children Act. For drugs still under patent, the law offered companies a patent extension if they would conduct specified studies in kids.

But for drugs with expired patents (so called "off-patent" drugs), another solution was needed. "Drugs that are off-patent have no value for big pharmaceutical companies," said Drover. "The profit margins are extremely low. And that means someone else now has to pay for the investigations that the companies never did in the pediatric population."

Under the 2002 law, that "someone else" is the federal government. Thus far, the FDA has created a list of 25 off-patent drugs needing clinical testing and has issued nine written requests asking pharmaceutical companies if they will do the work. When the companies decline, as they are almost certain to do, the NIH's National Institute of Child Health and Human Development steps in to fund the work. So far research contracts have been granted for just two drugs.

Under the contract awarded to Stanford, Greg Hammer and David Drover will spend three years conducting clinical and laboratory tests to determine the safety and effectiveness of sodium nitroprusside. This drug works to control blood pressure during anesthesia and in the intensive-care unit. The FDA listed it for testing because it is known to produce cyanide - the toxin people associate with suicide pills.


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