Program Does Encourage Pediatric Drug Studies

FDA 'pediatric exclusivity' program grants extension of drug marketing rights

WEDNESDAY, Sept. 13 (HealthDay News) -- The U.S. Food and Drug Administration's "pediatric exclusivity" program, whereby companies are granted a six-month extension of marketing rights for performing drug studies on children, has been successful, although only about half of studies are eventually published, according to a study in the Sept. 13 issue of Journal of the American Medical Association.

Daniel K. Benjamin, M.D. Ph.D. M.P.H., from the Duke Clinical Research Institute in Durham, N.C., and colleagues identified clinical trials conducted between 1998 and 2004 for pediatric exclusivity.

The researchers identified 253 trials that were submitted to the FDA. Half of the studies examined efficacy, 33 percent were single- or multiple-dose pharmacokinetic studies, and 17 percent were safety studies. Half of the studies resulted in positive labeling changes, the researchers found. However, only 45 percent of the studies were eventually published, with studies examining efficacy or resulting in positive labeling changes more likely to be published.

"The pediatric exclusivity program has been successful in encouraging drug studies in children," Benjamin and colleagues concluded. "However, the dissemination of these results in the peer-reviewed literature is limited."

Full Text (subscription or payment may be required)

Physician's Briefing