On December 18, 2001, the U.S. Congress approved a bill granting brand-name drug makers six months of marketing exclusivity after exclusive rights expire to allow them to test their medications on children. If signed by the president, the renewed bill would extend the current law for another five years, through 2007.
The original bill, passed in 1997, was amended to include generic drugs, giving the Food and Drug Administration authorization to investigate the effects of generics on children. A privately funded foundation would commission the studies by universities and organizations such as the National Institutes of Health, according to Reuters Health.
This amendment was added in response to criticism that the bill did not give generic drug makers the right to conduct such tests and in response to an attempt by Glucophage maker Bristol-Myers Squibb to keep a generic version of that drug (metformin) from being introduced.
Opponents of the original bill objected to the legislation because it would have postponed the arrival of less-expensive generic versions of brand-name drugs on the market. The revised version would allow generics to enter the market but would not allow their manufacturers to place pediatric information on the labels for three years.
The bill now awaits signature by President George W. Bush, Jr.
Dubbed the “Best Pharmaceuticals for Children Act,” the law was first passed to allow brand-name drug makers to test their products on children to determine the appropriate dosages for children and any possible side effects.
Glucophage, taken twice daily, is priced at $30.59. Glucophage XR, a once-a-day substitute, costs $23.99. Glucovance, made with Glucophage and a small amount of sulfonylurea, costs $29.39. The current price of metformin is $12.24, and the price of metformin with sulfonylurea is $23.63. (All figures reflect the retail price at New York drugstores for 30 pills of 500 mg each, as quoted in the Wall Street Journal.)