BioCentury
ARTICLE | Politics & Policy

Congress discusses pediatric drug incentives

May 3, 2001 7:00 AM UTC

FDA officials, members of Congress, industry representatives and patient advocates on Thursday expressed strong support for provisions of the FDA Modernization Act that provide incentives to drug sponsors to conduct pediatric trials. But they disagreed over whether the existing incentives, which provide sponsors an additional six months of market exclusivity in exchange for conducting pediatric trials, should be renewed after pediatric exclusivity provisions of FDAMA expire on Jan. 1, 2002. Republicans think the incentives are working well, while some Democrats want them changed.

Speaking at a hearing of the House Commerce Committee's subcommittee on health, Linda Suydam, senior associate FDA commissioner, said the incentives have led to a massive increase in pediatric testing. Rep. Jim Greenwood (R-Penn.) called the pediatric exclusivity provisions "a tremendous success." ...