FDA’s Pediatric Rule Hurts Public Health

Published March 1, 2001

A physicians’ association and two public interest groups filed suit in federal court, challenging the validity of the Food and Drug Administration’s “Pediatric Rule.” The lawsuit, filed on December 4 by the Association of American Physicians and Surgeons (AAPS), the Competitive Enterprise Institute (CEI), and Consumer Alert, is being handled by the law firm of Wiley, Rein and Fielding.

FDA’s Pediatric Rule, published on December 2, 1998, established a new policy under which FDA could require drug companies to perform pediatric testing for certain drugs even if pediatric uses were not part of the drug’s labeled indications.

The FDA claimed it was acting to protect children, but AAPS, CEI, and Consumer Alert charge the rule’s chief effect will be to add one more regulatory barrier to the drug approval process. As a series of CEI polls demonstrate, physicians overwhelmingly view FDA as already being too slow to approve new therapies.

Noted CEI General Counsel Sam Kazman, “Like countless other government measures, FDA’s Pediatric Rule is portrayed as ‘protecting children.’ Its major effect, however, may well be to delay new drug approvals and to enlarge FDA’s power beyond the limits set by Congress. The result would hurt public health, not advance it.”

The groups had previously petitioned the agency to withdraw the rule, but FDA rejected that petition in November 2000.

In support of the lawsuit, Dr. Henry Miller, a former FDA official, charged the rule “raises serious ethical problems about testing drugs on children before they have been fully tested on adults.” In a statement released when the groups’ petition was first filed, Dr. Russell C. Libby, a practicing pediatrician in northern Virginia, noted there are many drugs “approved in this country for adults, which are safe and effective for my patients.” The Pediatric Rule, he feared, might mean these “currently available drugs may actually become unavailable.”

AAPS is a non-profit organization of 4,000 physicians dedicated to preserving the practice of private medicine. CEI and Consumer Alert are nonprofit groups involved in opposing government over-regulation.

The law firm of Wiley, Rein, & Fielding is handling the case pro-bono. In 1999 the firm won a First Amendment court challenge to FDA’s ban on the distribution of off-label research publications.


Richard Morrison is associate director of media relations at the Competitive Enterprise Institute. He can be reached by phone at 201/331-1010, ext. 266.