BioCentury
ARTICLE | Politics & Policy

Public Citizen assails poor phase IV compliance

April 13, 2000 7:00 AM UTC

An analysis of data obtained from the FDA indicates that drug sponsors have a poor record of compliance with commitments to conduct post-marketing studies, according to a study released Thursday by Public Citizen's Health Research Group, a consumer organization affiliated with Ralph Nader.

Citing the FDA data, the study indicates that from 1990 through 1994, sponsors of 88 new molecular entities (NMEs) agreed to conduct Phase IV studies and that as of December 1999 only 11 had been completed. "For the 107 NMEs with Phase IV commitments approved between January 1995 and the end of 1999, not one drug had been classified by the agency as having completed commitments as of December 23, 1999," the consumer group reported. ...