Bill to Boost Child Drug Trials OK'd by Senate Panel
Aug. 1, 2001 (Washington) -- Legislation giving drug companies renewed financial incentives to study the safety and benefits of medicines among children unanimously passed a Senate committee Wednesday.
Nevertheless, the measure may prove more contentious later this year, when it reaches the full Senate after the month-long congressional summer recess. During the panel's consideration of the bill Wednesday, several senators expressed interest in adding amendments to address fears that the program increases consumer costs.
Under the program, enacted in 1997, a drug company gains six bonus months of patent exclusivity (where they are the only makers of a drug) against potential generic competitors if it agrees to fund and conduct studies of that medication among children.
Unless Congress reauthorizes the program, it will expire on Jan. 1, 2002.
According to Sens. Chris Dodd (D-Conn.) and Mike DeWine (R-Ohio), who sponsored the 1997 bill, the program has been extraordinarily successful in helping doctors better understand how to use drugs in children. The senators noted that 332 pediatric drug studies have begun since the initiative began, whereas just 11 studies had been conducted in the prior six years.
Sen. Edward Kennedy (D-Mass.), chairman of the Senate's health panel, agreed that the program has been "impressive," but added that it had not been an "unqualified success."
Kennedy said that amendments were necessary to make sure that new information about a medicine makes it onto drug labels more rapidly, and to address "the unnecessary delay in consumer access to cheaper generic drugs when brand-name drugs receive an extra six months of market exclusivity."
The customer advocacy group Public Citizen is arguing that testing of drugs in children should be required before drugs are approved at all. According to the group, "It is the only solution that puts the burden for the safety of drugs ... squarely on the shoulders of the drug industry ... rather than on the backs of consumers."
Sen. Hillary Clinton (D-N.Y.) is sympathetic to this argument. She said Wednesday that drugmakers in some cases are getting more than their fair share in doing the children's trials under the incentive program. According to Clinton, a trial that costs a drug company less than $8 million can bring it additional patent exclusivity worth $1 billion in profits.