U.S. Senator Lamar Alexander today joined Senator Wayne Allard (R-CO) in proposing an amendment to preserve incentives in the Best Pharmaceuticals for Children Act – which has been law since 1997 – that are already working to improve the effectiveness of prescription drugs for children. The amendment failed to pass by a vote of 41 to 53.
“My mother used to tell me ‘don’t try to make a happy baby happy, just leave it alone.’ We ought to take that advice here and not try to make this happy legislation happy,” Alexander said during a debate on the Senate floor. “For a decade, this law has helped provide worried parents and concerned physicians with needed information to make better decisions in prescribing treatment for young children.”
The Allard-Alexander amendment would continue to encourage pharmaceutical companies to test more drugs for use on children by extending the current policy of giving those companies and extra six months on their drug patents in exchange for conducting further testing of how medicines affect children. The FDA authorization bill now pending before the Senate would cut that incentive to three months for certain drugs.
“By extending drug patents in exchange for additional research on how these drugs affect children, this program has prompted studies on 144 products and led to 122 label changes on some of the most frequently prescribed drugs for children,” Alexander said. “Clearly the system works and should be continued, especially since only a third of drugs prescribed to children have yet been studied and labeled for children.”
Alexander noted that giving children medicines designed for adults can have adverse effects. “Seven Tennessee babies who were prescribed an antibiotic to treat whooping cough in 1999 became so seriously ill that they needed stomach surgery,” said Alexander. “The Centers for Disease Control linked their illness to the antibiotic, which had never been tested in young children.”