 
News of the Day ... in Perspective12/07/2003President signs Pediatric Research Equity Act In this legislation, Congress nullified the recent AAPS court challenge to the Pediatric Rule, giving the Food and Drug Administration the authority it previously lacked to force drug companies to test drugs in children before releasing them for use in adults. The bill, strongly supported by Sen. Hillary Rodham Clinton (D-NY), lacks safeguards to protect children from exploitation. Collaborative business arrangements between drug companies and physicians in universities, clinics, and private practice provide financial incentives to enroll children in experiments from which they may bear significant risk of harm without prospect of benefit. Additional information AAPS wins pediatric drug case: FDA oversteps its authority Possible impact on “off-label” prescribing (AAPS News January 2000) |