FDAMA Involvement

The PPRU has played a major role in implementation of the Food and Drug Administration Modernization Act (FDAMA). Since FDAMA, the FDA has issued 145 requests for pediatric studies. Company sponsors have designed and conducted pediatric studies in response to the requests, resulting in twenty-two marketed drug products being granted exclusivity. The PPRU has performed all or part of the clinical trials supporting the exclusivity determination for eight of these drugs. During 1998-99, pediatric labeling was added to six marketed products based on studies conducted under FDAMA provisions. The PPRU conducted the studies to support the labeling changes of four of these six products.

Drugs for which PPRU did studies to support exclusivity extension include:

Enalapril, Ibuprofen (2 products), Metformin, Midazolam, Propofol, Ranitidine, Tramadol

Drugs for which PPRU did studies to support pediatric labeling include:

Ibuprofen (2 products), Midazolam, Ranitidine