Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Associated Press, Saturday November 28, 1998
Will Lester, Associated Press Writer
"We are committed to ensuring that health care providers get the best information they need to treat children," said Dr. Michael A. Friedman, the agency's acting commissioner.
Every year, more than half of the newly approved drugs that are likely to be used by children have insufficient information from the manufacturers about safe pediatric use, according to the FDA.
The rules are intended to make the manufacturers give doctors and other health care providers more complete information on pediatric use so they will not be hesitant to prescribe needed drugs.
The FDA cited examples of seizures and cardiac arrest as well as teeth staining and withdrawal symptoms related to inappropriate dosages of drugs for children. The classic example of the problem has been with AIDS drugs, many of which were approved without pediatric testing, FDA officials said. In some cases, companies went back and did testing to determine correct dosages for children only after the drugs were approved.
"These regulations mean that - finally - children can share in the research progress against disease," said actor Paul Glaser, who lost his wife and daughter to AIDS and whose son is HIV-positive.
"Most of the time, children have been an afterthought in pharmaceutical research," said Susan DeLaurentis, a co-founder of the Elizabeth Glaser Pediatric AIDS Foundation, named after Glaser's late wife.
Pharmaceutical industry officials have said they already provide such information for many drugs, and questioned whether a federal mandate is needed. The regulations will ensure that such labeling is done routinely on the drugs. Officials of Pharmaceutical Research and Manufacturers of America said Friday they had not seen the new regulations and would not comment immediately.
The rules also allow the FDA to require pediatric testing of products that are already being sold, for example in cases when a drug is commonly prescribed for children's use without adequate labeling and could cause significant risk. One of the regulations allows the agency to defer testing on children until needed testing information is gathered from adults.
Even if the drug is one that is commonly used by children, the pediatric study requirement can be waived entirely if:
- The FDA finds that the product is likely to be unsafe or ineffective in pediatric patients.
- Pediatric studies are impossible or highly impractical.
- Reasonable efforts to develop a pediatric formulation have failed.
981128
AP981122
Copyright © 1998 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.
Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .