Challenge to Pediatric Drug Rule Rejected.

Chemical Market Reporter, May, 1999 by HESS, GLENN

FDA and brand-name pharma industry score a victory over generic manufacturers. A FEDERAL COURT has denied the generic drug industry's request for an injunction to stop the Food and Drug Administration's program to promote research on the safe and effective use of medicines for children.

Judge James Robertson of the US District Court for the District of Columbia ruled that "the public interest would be disserved by an injunction whose operation would be to remove the incentive for testing [of medicines for children.]" The lawsuit was filed in February by the Generic Pharmaceutical Industry Association and the National Pharmaceutical Alliance. The generic industry wanted to block FDA from implementing new pediatric drug study rules that they...

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