Pediatric testing of prescription drugs: the Food and Drug Administration's carrot and stick for the pharmaceutical industry.

Introduction........................................................................................ 740 I. Pediatric Testing: A Historical Perspective of the “Therapeutic Orphan” ............................................................. 746 A. Past Attempts to Acquire Pediatric Labeling.................... 746 B. FDAMA Section 111—Pediatric Exclusivity...................... 749 C. FDA’s Mandatory Final Rule ............................................. 753 II. FDA’s Questionable Authority and Intent to Mandate Pediatric Studies ....................................................................... 755 A. FDA’s Lack of Authority to Mandate Pediatric Testing... 756 1. The FDA’s misplaced reliance on statutory authority ....................................................................... 756 a. New drugs ............................................................... 757 b. Currently-marketed drugs...................................... 760 2. FDA officials’ acknowledgment of FDA’s lack of authority to mandate pediatric testing........................ 761 B. FDA’s Intention to Expand Pediatric Testing Requirements After FDAMA Section 111 Sunsets ........... 763