December 19, 2001

WASHINGTON (AP) - Lawmakers on Tuesday sent President Bush a bill that encourages drug companies to test their products for use by children.

The House passed the measure by a voice vote Tuesday. The Senate passed it last week.

The bill renews a 1997 law that gives drug companies an additional six months of patent protection when they conduct pediatric tests. The law had been set to expire this year.

"For all of the health history of this country, we have had a serious problem in trying to get pharmaceutical companies to test their products on children so pediatricians can prescribe this medicine," said Rep. Jim Greenwood, R-Pa.

As a result, many drugs prescribed to children have never been formally tested or approved for pediatric use and lack even basic dosage recommendations for children in their labeling, lawmakers said.

Since the law was enacted, over 400 pediatric drug studies have taken place, compared with 11 studies in the six years prior to the legislation.

"Guessing may work for cooking, but when it comes to medicine for children, it is a recipe for disaster," said Sen. Chris Dodd, D-Conn. "This measure helps remove any guesswork and dramatically improves health care for our nation's children, while also offering increased peace of mind for their parents."

In drafting language, lawmakers rejected attempts by Bristol-Myers Squibb Co. to extend its patent for the diabetes drug Glucophage.

The company had wanted the right to market the drug, which accounts for $1.8 billion in annual sales, for another three years, claiming tests show that teen-agers can benefit from the drug.

Consumer groups and the generic drug industry had complained loudly.