Monday, January 29, 2001
WASHINGTON - The pediatric exclusivity provision of the FDA Modernization Act (FDAMA) has been a great success and it should be reauthorized before it sunsets next Jan. 1, according to a report FDA has submitted to Congress. The agency also is recommending that Congress increase incentives for testing pediatric indications for off-patent and low-selling drugs as well as for very young children.
FDAMA, which was passed in 1997, authorized FDA to grant manufacturers an additional six months of market exclusivity in return for conducting pediatric studies for drugs that are identified by FDA. As a result of this provision, according to FDA, the agency "has issued over 157 written requests, asking for 332 studies that would potentially involve over 20,000 pediatric patients. In less than 3 years, over 58 pediatric studies have already been conducted, study reports submitted, and exclusivity granted to 25 drugs."