News in brief - April 3, 2000

High court denies FDA bid to regulate tobacco - FDA pulls controversial type 2 diabetes drug - Clinton calls for caution in medicating kids

High court denies FDA bid to regulate tobacco

Washington -- In a major setback to the Clinton administration's anti-smoking efforts, the Supreme Court ruled 5-4 that the Food and Drug Administration overstepped its bounds when it sought to crack down on tobacco sales to minors.

Writing for the majority, Justice Sandra Day O'Connor asserted that the court did not question the seriousness of the problem: "Tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States." But Congress did not provide the agency the power it was attempting to assert, according to the March 21 opinion.

Until it issued a controversial regulation in 1996, the FDA had maintained that it did not have authority under a 1938 statute to regulate tobacco unless cigarette manufacturers made specific health benefit claims. However, in the 1996 rule, the agency said new evidence opened the door to oversight. The industry sued to block its implementation. The Supreme Court considered the question after a 1998 Fourth Circuit Court of Appeals found against the agency.

Public health advocates renewed calls for congressional action. "We stand ready to assist Congress in passing responsible bipartisan legislation that would rectify the Supreme Court's unfortunate decision," said Randolph D. Smoak Jr., MD, AMA president-elect. Others pointed out that the court had reaffirmed that tobacco use was a public health crisis and that public policy is inadequate to address the need for its regulation.

FDA pulls controversial type 2 diabetes drug

Morris Plains, N.J. -- Parke-Davis, a division of Warner Lambert, withdrew Rezulin (troglitazone) from the market following the FDA's determination that the drug "poses an unacceptable risk to patients." The company said it continues to believe that the benefits of the type 2 diabetes drug outweigh its associated risks, but recommends that patients consult their physicians to discuss alternatives.

Clinton calls for caution in medicating kids

Washington -- In response to reports of a dramatic increase in the number of children younger than 4 prescribed psychotropic drugs, Hillary Rodham Clinton launched an initiative to provide parents more information and guidance. The Feb. 23 JAMA reported that from 1991 to 1995, Ritalin prescriptions for 2- to 4-year-olds jumped threefold. The number of children on antidepressants doubled during that period.

Clinton unveiled four actions: The National Institute of Mental Health will release a fact sheet on when medication should be given, how to determine if problems are serious, and how to get help. The Dept. of Education will release an information kit. NIMH also will commit $5 million for research on the impact of psychotropic medication on young children. And the FDA will work to improve pediatric labeling information. In addition, a conference on treating children with behavioral and mental disorders will be held this fall.

The first lady also praised efforts by the American Academy of Pediatrics and American Academy of Family Physicians. This spring, AAP will distribute new clinical practice guidelines on the diagnosis and evaluation of children with attention deficit disorder. AAFP will sponsor courses for its members.