FDA to Begin Requiring Pharmaceutical Companies to Test Children’s Dosages

On Dec. 2, a two-year-old FDA regulation becomes effective that requires pharmaceutical companies to study how new medicines affect children, the Chicago Tribune reports. The "Pediatric Rule of 1998" states that the scientific studies needed to prove that drugs are safe and useful for adults must also be conducted to show they are safe for children. The regulation aims to give physicians more complete research on how drugs affect children, resulting in more appropriate medical treatment for children across the country. Some children's medicines, such as Children's Tylenol and Junior Strength Motrin, are marketed and labeled for use in children. Some are also tested and approved for children by the FDA. Many others, however, are not. The FDA estimates that each year "more than half" of newly approved drugs likely to be used in children are not "adequately tested or labeled for treating youngsters." The National Institutes of Health estimates that nearly 75% of all medications marketed today do not carry labeling for use in infants, children and adolescents, and many prescriptions written by doctors for children are for "off-label" use, meaning that they have been approved by the FDA for use in adults, but not children. The "inadequate information" on the effects of medicines in children often leads to children not healing as a result of undermedication, or suffering adverse side effects due to overmedication. "Kids are evolving," said Dr. Dianne Murphy, associate director for pediatrics at the FDA's Center for Drug Evaluation and Research. "As they evolve, different things turn on and off, different enzymes, different receptors become inactive or active, and because of that, their susceptibility and responses are different." Murphy said that children have traditionally been "wrongly treated like smaller versions of adults" when it comes to medicines. Several times, the lack of information has resulted in medical mishaps. In the mid-1980s, verapamil, a drug used safely in adults to treat high blood pressure and heart disease, "unexpectedly" caused cardiac arrest in infants who were given the drug to treat irregular heartbeat. Earlier this decade, a local anesthetic used on children under 12 "unexpectedly" caused seizures due to overdosing. In 1997, legislation asking drugmakers to voluntarily test their products for children was issued. As a result, 13 medications changed their labels to reflect pediatric information.

Pros and Cons
Physicians support the regulations, stating that it will "help end the guesswork" involved with dosing medications for children. Dr. Ralph Kauffman, director of medical research at Children's Mercy Hospital in Kansas City, Mo., said, "When drugs are used widely in children without research, we've been subjecting each individual child to an uncontrolled experiment without supervision and without learning anything; that has been going on for the last 30 years." The regulation is meeting opposition from pharmaceutical companies, however, who say that it could delay drug approvals for adults. The FDA said it will not allow such delay. In addition, drug manufacturers also stated that the rule could "force them to test drugs in children that they don't intend to market for children," the Tribune reports. Marjorie Powell, assistant general counsel with the Pharmaceutical Research and Manufacturers of America warned that the regulation could lead to future requirements to test drugs in other populations, such as seniors or certain minority groups. While the drug industry has adopted a "cautious wait-and-see" attitude toward the regulation, some "industry insiders" expect legal action against it once it is enacted. Pharmaceutical manufacturers have said they "aren't planning on" such a move right now (Christian, Chicago Tribune, 12/1). In addition, the FDA has more information on the Pediatric Rule at http://www.fda.gov/cder/present/dia-62000/vicrac1/index.htm.