Pros And Cons Of Bcpa

BCPA & PREA: Effects & Challenges

The Problem the BCPA & PREA Addresses Prior to the 1990s, only about twenty percent of all drugs prescribed for children in the United States were ever tested for safety or efficacy. Currently, dediatricians have to decide what is appropriate to prescribe for children for more than half of medications that do not include specific labeling for children. The Food and Drug Administration (FDA) requires that drugs be tested for safety and efficacy in a specific population, at a specific dosage, and for a specific time period before a drug is FDA approved for clinical use. Most clinical research for FDA approval protocol excludes children. Children are more vulnerable to adverse drug reactions and therefore

The American Academy of Pediatrics (AAP) believes that even though a drug is considered off-label for children this does not mean the drug is improper or only experimental use. Rather, drug’s off-label status does not imply an improper or experimental use. Pediatricians have the ability to properly decide when it is proper for a child to be prescribed an off-label drug and can rely on either expert opinion or evidence that is used for another population. However, off-label use of drugs limits the ability for the pediatric medical community to gather necessary clinical knowledge of the drug product especially determining how the drug metabolism and response changes during a child’s growth and development and whether the drug has long or short term

The Better Pharmaceuticals for Children Act (BCPA) was introduced in 1992, 1994, 1996, and 1997 before it was finally enacted as part of the Food and Drug Administration Modernization and Accountability Act (FDMA). The BCPA is considered the “carrot approach” because drug sponsors of already approved drugs may receive a patent extension if they voluntarily choose to perform FDA-requested pediatric research through the Pediatric Exclusivity Provision. The Pediatric Research Equity Act (PREA) was introduced and enacted in 2003. The PREA is considered the “stick approach” because the FDA has authority to require pediatric studies for certain sponsors that submit an application for an approved drug that is wanting a new indication, active ingredient, dosage form, dosing regimen or route of