Bill Extends Benefits to Companies That Test Drugs in Children

A bill renewing a 1997 federal law giving pharmaceutical companies a financial incentive to test drugs in children was passed by Congress last month. The president is expected to sign the bill (S 178) this month.

The Best Pharmaceuticals for Children Act extends the pediatric testing provisions in the 1997 FDA Modernization Act for another five years and adds new provisions to strengthen the program.

The legislation requires pharmaceutical companies submitting new drug applications with the FDA to show that they conducted studies on children. The law also extends drug patents for six months if the drug is considered to be important to study in children, and the drug companies agree to conduct the studies.

The law was prompted by the fact that fewer than 20 percent of medications on the market in 1996 were studied or approved for use in children. Yet many medications were being prescribed without important information about safety, efficacy, and side effects in children.

Concerned about the lack of pediatric prescribing information led physician groups including APA, the AMA, and the American Academy of Child and Adolescent Psychiatry to advocate for the pediatric testing provisions in the 1997 law and its renewal last year.

Since 1997, drug companies have undertaken more than 400 pediatric studies on a wide range of drugs, of which 58 have been completed, according to the bill’s sponsors. In addition, the FDA has granted patent extensions to 53 drug companies for undertaking studies of their products in children.

Pediatric patent extensions have been granted for three psychotropic drugs—fluoxetine (Prozac), buspirone (Buspar), and fluvoxamine (Luvox). Only fluvoxamine, however, was approved by the FDA for a label change for the treatment of obsessive-compulsive disorder in youth (Psychiatric News, July 6, 2001).

The results of a study of fluvoxamine by Solvay Pharmaceuticals showed that a dose increase may be necessary in adolescents and that girls from 8 to 11 years of age may require lower doses. By contrast, the results of a study of buspirone by Bristol-Myers Squibb did not support that the drug was safe or effective in treating general anxiety disorder in youth from 6 to 17 years of age at doses recommended for adults, according to the FDA.

Eli Lilly, the maker of fluoxetine, was granted a six-month extension to study its drug in children, but the results were not informative enough to warrant a label change, according to the FDA.

Because the FDA cannot mandate that drug companies with existing patents study their products in children, the 1997 law was amended in the 2001 bill to allow the National Institutes of Health Foundation to serve as a funding mechanism for studies of drugs in children that might not be done otherwise because their manufacturers declined to study them or because they have expired patents, according to the legislation.

In addition, drug companies will have to respond to the FDA’s written requests to conduct studies and make label changes within specific timeframes set out in the legislation. The FDA has a priority list of approximately 25 psychotropic drugs for which it has issued about 12 written requests for studies.

For example, a drug company has 30 days to make a FDA-requested labeling change. Otherwise, the FDA can label a drug misbranded if it attempts to market it for an unapproved use, according to the legislation.

The bill also requires the secretary of Health and Human Services to establish an Office of Pediatric Therapeutics to coordinate all FDA pediatric activities and to contract with the Institute of Medicine to review federal regulations, reports, and support for research involving children, paying particular attention to issues of informed consent, payment, and benefit/risk assessments in research.

The text and a summary of the Best Pharmaceuticals for Children Act is available at the Thomas legislative Web site at thomas.loc.gov by searching on the bill number, “S 1789.” ▪