Pediatric Drug Testing Bill Could Endanger Lives

Washington, D.C., February 26, 2003—A controversial pediatric drug-testing bill will soon be introduced in the Senate, but according to a public interest group it could actually endanger public health.  The Competitive Enterprise Institute argues that the bill, if enacted, could delay the introduction of new drugs.  CEI was one of three groups that succeeded last fall in getting a similar FDA regulation overturned in court.  The court ruling has now become the impetus for this legislative proposal.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />


Under the Pediatric Rule, issued by FDA in 1998, the agency could demand that drug manufacturers perform pediatric testing on adult drugs that are used “off-label” for children.  Even though a drug may be labeled for use by adults only, it would have to be tested on children if there was a likelihood that pediatricians would use it.  The agency claimed it was acting to protect children, but CEI and the other plaintiffs—Consumer Alert and the Association of American Physicians and Surgeons—argue such a testing mandate would lengthen the drug approval process, resulting in fewer new drugs overall.


“Having more data on drugs sounds wonderful, but there is a trade-off between having more information and having more drugs.  And many doctors, if they have to choose, would choose to have more drugs,” said Sam Kazman, CEI’s general counsel and an expert on FDA policy issues.  “The Pediatric Rule constituted a drastic change in the drug approval process, and it should not be replicated by Congress.  The end result could be a far riskier and costly approval process, and ultimately, fewer drugs.  No one would benefit from that.”


For more information about this issue, a backgrounder is available online, in addition to the federal court’s decision and a CEI poll of doctors about the FDA’s drug lag.

FDA Expert Available for Interviews on Pediatric Drug Testing

Sam Kazman

General Counsel


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