OFFICE OF NEW DRUGS MODULE

Pediatric Research Equity Act (PREA)

PREA was passed in 2003, and reauthorized with some changes in 2007. PREA:

• Is triggered by an application for a new indication, new dosage form, a new dosing regimen, a new route of administration or a new active ingredient.
• Authorizes FDA to require a pediatric assessment of some approved drug/biologic products for certain indications. The pediatric assessment contains data using appropriate formulations for each age group that is adequate to assess the safety and effectiveness of a drug or biologic for the claimed indications in all relevant pediatric subpopulations. In addition, the data need to be adequate to support dosing and administration for each pediatric subpopulation. An assessment, at the minimum, will typically comprise pharmacokinetic or pharmacodynamic data and safety studies. Sometimes, FDA will allow the extrapolation of efficacy, or it will require full safety and efficacy studies. In some cases, FDA will accept literature review for a drug that has been in the marketplace for a long time, although this is rare.