FDA could endanger children with rule suspension

In a ruling that can only help multibillion dollar pharmaceutical companies, the Food and Drug Administration plans to suspend a federal requirement that drugmakers test their products for safety and effectiveness in children. Where children are concerned, the government should be erring on the side of health and safety, not the drug industry's bottom line.
The FDA plans to suspend the rule for two years to see if it's really needed. But pediatricians and child health care experts are greatly concerned about the danger to children if physicians are forced to determine child-appropriate doses from information on adult dosage, without even knowing whether the drugs have the same effect in children as they do in adults.
In a letter to President Bush, U.S. representatives Sherrod Brown, D-Ohio, Henry A. Waxman, D-Calif., and John D. Dingell, D-Mich., have asked that the FDA be directed "to reverse course and preserve this important safety measure." Brown is the ranking minority member of the Congressional Subcommittee on Health. The Bush administration should not let partisanship get in the way of responding to this significant issue..
As recently as 1995, Paula Botstein, M.D., deputy director of FDA's Office of Drug Evaluation I, said that children can't simply be given a smaller dose of a given drug because, "Young children may metabolize or absorb drugs at a different rate from adults, and therefore a suitable dose is difficult to estimate from the size of the children."
Voluntary efforts not enough: As a result of the widespread concern expressed at that time that voluntary efforts by the pharmaceutical industry to undertake testing of their products for children were inadequate, the FDA finalized a rule requiring manufacturers of many drugs to provide information about how their drugs can safely and effectively be used in children from newborns to adolescents, including information on the proper doses for kids.
That rule was further enhanced with the passage of the new Best Pharmaceuticals for Children Act, which extended by six months patent protection for each medicine that drug makers study in children -- a financial windfall -- and set up a grant program to allow taxpayer dollars for pediatric studies of drugs their makers, despite the incentives, won't do.
Pediatricians and child health experts welcomed the new rule, which went unchallenged -- aside from industry grumbling -- until a lawsuit was filed by a conservative think tank and the Association of American Physicians and Surgeons, a group that opposes Medicare, the mandatory vaccination of children and the patient's bill of rights. Their attorney was subsequently appointed as the FDA's chief counsel -- his recusal from the case comes a little late.
The FDA, too quickly, has been turned from an agency that protects the American people into an agency that protects the American pharmaceutical industry. The nation's children deserve better.