Now US Senate passes pediatric test bill

Following the earlier US House Energy and Commerce Committee approval tocontinue the 1997 legislation providing additional exclusivity if pediatric testing of drugs is conducted (Marketletter October 22), the Senate also passed this, by a voice vote, on October 18. No date has yet been set for a House vote.

Originally passed in 1997, the bill's aim was for drugmakers to conduct studies to establish appropriate dosing for children and reveal any adverse events.

In renewing the legislation, notes Reuters, the Senate has also authorized the Food and Drug Administration to investigate the effects that generic drugs might have on young children. The bill provides for privately-funded foundation to commission these studies from various organizations, including universities, the Institute of Medicine and the National Institutes of Health. Brand-name pharmaceutical companies have conducted 400 additional studies and the FDA ssays it has uncovered a number of previously undocumented dosing errors and adverse events.