Pediatric Research Equity Act

In 2003 Congress enacted the Pediatric Research Equity Act (PREA) to further promote drug study in the pediatric population. Here the FDA was given the authority to require studies for the registration of a new drug when deemed necessary. Therefore, now the FDA has both a carrot (BPCA) and a stick (PREA) to encourage the study of drugs in pediatrics. 

Food and Drug Administration (2003). The Pediatric Research Equity Act. Public Law 108-155 (December 3, 2003). http //www.fda.gov/cder/pediatric/S-650-PREA.pdf (accessed January 2006). 

The general basis of U.S. FDA food lead control regulation and how it performs this function is spelled out in two basic statutes. These are, to a limited extent, the Food and Drug Act (F D Act) of 1906 and the 1938 FFDCA. A number of important amendments to the 1938 Act have been enacted over the years, and those of particular relevance to the topic at issue are as follows (1) the Infant Formula Act of 1980 [PL 96—359] (2) Dietary Supplement Health and Education Act of 1994 [PL 103—417] (3) Food Quality Protection Act of 1996 [PL 104—170] (4) Pediatric Research Equity Act of 2003 [PL 108—155] and (5) the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 [PL 109—462]. 

Some significant amendments to the FDCA infant Formuia Act of 1980 [PL 96-359] Dietary Suppiement Heaith and Education Act of 1 994 [PL 103-4171 Food Quaiity Protection Act of 1996 [104-1 70] Pediatric Research Equity Act of 2003 IPL 108-1551 ... 

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