FDA Guide To Interpreting Pediatric Exclusivity

Even if the US Food and Drug Administration issues a written request toa drug sponsor for pediatric studies, it is the sponsor's decision whether to conduct the studies and possibly gain pediatric exclusivity, according to an interim FDA guidance to assist industry in interpreting the pediatric exclusivity section of the Food and Drug Modernization Act (Marketletter June 8). Qualifying for pediatric exclusivity under Section 505A of the Federal Food, Drug and Cosmetic Act will remain in effect until regulations are issued through notice and comment rulemaking.

The FDA will first review proposed pediatric study requests submitted on or before August 31 for any of the 490 drugs that appear in the priority pediatric list the agency issued on May 20 for which any exclusivity or patent period expires on or before March 31, 1999. According to the guidance, the FDA will decide on a written request by October 15, 1998.

The FDA will then review any other proposed pediatric study requests for approved drugs that appear in the priority section of the list and proposed pediatric study requests submitted for drugs that are not yet approved.