Pediatric Labeling Urged for More Drugs


Pediatric Labeling Urged for More Drugs

Pediatric-use labels would provide a lasting guidance for medical professionals who treat infants, children, and adolescents.

In the 16 months since issuance of guidance to industry for the pediatric studies provision of the FDA Modernization Act of 1997 (FDAMA), there have been more than 220 requests made by FDA for studies on important drugs that need additional pediatric information. This increase in the number of drugs studied specifically for children is unprecedented and encouraging.

The American Academy of Pediatrics (AAP) and the Pediatric Academic Societies have been enthusiastic supporters of the efforts that Congress and FDA have taken on behalf of the pediatric population. And we watch and wait for evidence that the ultimate goal of this legislation is being reached—that the number of new and already-marketed drugs are not only studied in infants, children, and adolescents, but are also labeled for treatment of pediatric patients to provide lasting guidance for all physicians who prescribe medications for young patients.

In 1997, Congress led the way by establishing a five-year program intended to improve the information available to these health professionals. The six-month extension of the market exclusivity of new and already-marketed drugs for which pediatric studies are completed has proved to be a very effective incentive that pharmaceutical companies are pleased to embrace. But the reality is that incentives alone will not complete this critical process for safeguarding children's health.

Myron Genel, MD, fellow, American Academy of Pediatrics (Washington, D.C.)

In 1998, FDA released regulations that would complement the new pediatric studies law. Recognizing that there would be gaps in the type and scope of drugs captured by the law, FDA put in place regulations that would require pharmaceutical companies to study new and already-marketed drugs for pediatric populations in certain circumstances.

For those drugs that may not be deemed necessary for pediatric study by the pharmaceutical industry, even though pediatricians and other health professionals may view the drugs as important for children, FDA has the ability to require that studies be conducted for pediatric populations.

However, there still remains an outstanding therapeutic issue for children. Off-patent drugs (those whose market exclusivity has expired) need to be studied and labeled for use in pediatric populations. This is a large and very important group of drugs with wide use in children but with limited pediatric labeling. Neither FDAMA's pediatric exclusivity provision nor the 1998 FDA regulations fully capture off-patent drugs. Currently, there is little incentive for companies to conduct pediatric studies on this group of drugs.

The AAP and the Pediatric Academic Societies have recommended the following to FDA in a prepared testimony:


  • FDA should implement an evaluation tool for determining the scope, nature, and type of labeling changes accomplished as a result of FDAMA provisions for various pediatric populations.


  • The AAP and the Pediatric Academic Societies offer assistance to FDA as they explore issues related to ensuring a broad base of pediatric studies conducted in a safe, effective manner in infants, children, and adolescents.


  • The AAP and the Pediatric Academic Societies urge Congress to provide funding for FDA staff who will be required to review and approve the increasing number of pediatric studies that will be generated as a result of FDAMA to maintain the progress that has been made in these first two years.


  • The AAP and the Pediatric Academic Societies urge FDA and Congress to continue to seek avenues for getting off-patent drugs tested and labeled for infants, children, and adolescents.

For further information, contact the American Academy of Pediatrics, Dept. of Federal Affairs, 601 13th St. NW, Ste. 400 North, Washington, D.C. 20005; phone 202/347-8600. Dr. Genel's full testimony is available on the Web.



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