FDA's Pediatric Rule Challenged in Federal Lawsuit

FDA's Pediatric Rule Challenged in Federal Lawsuit

On Its 2nd Anniversary, Three Groups Charge the Rule is Arbitrary and Illegal
December 03, 2000

Washington, DC, December 4, 2000 – A physicians’ association and two public interest groups today filed suit in federal court challenging the validity of the Food and Drug Administration’s “Pediatric Rule.” The lawsuit, brought by the Association of American Physicians and Surgeons, the Competitive Enterprise Institute, and Consumer Alert, is being handled by the law firm of Wiley, Rein & Fielding.

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The FDA’s Pediatric Rule, published on Dec. 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 in the view of AAPS, CEI and Consumer Alert, the rule simply adds 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. CEI General Counsel Sam Kazman stated: “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 this past November. In support of the lawsuit, Dr. Henry Miller, a former FDA official, charged that 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 that there are many drugs “approved in this country for adults, which are safe and effective for my patients”; his major concern was that, under the Pediatric Rule, these “currently available drugs may actually become unavailable.”

 

The Association of American Physicians and Surgeons is a non-profit organization of 4,000 physicians dedicated to preserving the practice of private medicine. The Competitive Enterprise Institute and Consumer Alert are nonprofit groups involved in opposing government overregulation.

 

The law firm of Wiley, Rein, & Fielding is handling the case pro bono. In 1999 it won a First Amendment court challenge to FDA’s ban on the distribution of off-label research publications. For more information, please call Richard Morrison at 202-331-1010, or email him. Or call Consumer Alert’s James Plummer at 202-467-5809, or email him.