FDA: New Rules Mandate Pediatric Drug Testing
The Food and Drug Administration issued new rules Friday requiring pharmaceutical manufacturers to conduct pediatric clinical trials of new drugs and include children's dosages on drug labels. The New York Times reports that the finalized regulations, which have the backing of President Clinton, "met strenuous objections from many drug companies," who charged the requirements were "impractical and burdensome" (Pear, 11/28). The FDA decision comes in response to concerns that fewer than 50% of drugs that reach the market each year specify appropriate pediatric dosages, which contribute to doctors' hesitation "to prescribe needed drugs" to children. The AP/Baltimore Sun reports that children with AIDS are particularly impacted by the new rules, as many AIDS drugs received FDA approval without undergoing pediatric clinical trials (11/28). "Most of the time, children have been an afterthought in pharmaceutical research," explained Susan DeLaurentis, co-founder of the Elizabeth Glaser Pediatric AIDS Foundation (Lester, AP/New York Daily News, 11/28). The Times reports that many pharmaceutical companies avoid the hassle of conducting pediatric trials by extrapolating from adult data and noting on drug labels that "[s]afety and effectiveness in pediatric patients have not been established." However, under the new FDA regulations, which will take effect April 1, products must be tested on children "if the product is likely to be used in a substantial number of pediatric patients," or if the drug is expected "to provide a 'meaningful therapeutic benefit' over existing treatments for children of similar ages." In addition, the rules include provisions which require companies to conduct clinical trials on children of varying age, spanning the years from birth to adolescence. However, the rules stipulate that products for which testing would be "highly impractical" or create "undue risks for pediatric patients" are exempt.
The Times reports that the new rules are "in some ways more flexible" than those initially proposed by the Clinton administration in August 1997. Under the new regulations, companies may defer pediatric testing until preliminary testing in adults indicates the drug's safety and efficacy. William Schultz, deputy commissioner of the FDA, explained, "We do not expect to hold up the approval of new drugs for adults even if the study in children was inadequate. Instead, we'll approve the drugs for adults and then require studies in children." And the FDA indicated that in instances where similarly effective pediatric drugs are already available, the agency might loosen the restrictions and allow companies to postpone pediatric trials. The final rules are "much broader" in scope than the Clinton proposal because they would apply to all drugs seeking FDA approval that have "a new active ingredient, a new use for the drug, a new dosage form or a new way for patients to take the drug." The older version of the rules required that "any new drug be tested in children." The Times reports that "drug companies including Merck & Company, Glaxo Wellcome, Novartis and the Wyeth-Ayerst Laboratories division of the American Home Products Corp.," charged that compliance with the new regulations would prove "impractical and burdensome." The companies also predicted that the rules will eventually spur a flurry of lawsuits from children injured in the drug tests, as the companies "could not obtain informed consent from children." Although the rules have sparked concern among pharmaceutical companies, the Times notes that they have been praised by patient advocates and physicians alike. Timothy Westmoreland of Georgetown University Law Center commended the ruling, saying, "It is much more unethical to expose children to drugs of unknown safety than to put the children into carefully controlled clinical trials" (Pear, New York Times, 11/28).