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Safe & Effective Drugs for Children

Reauthorization of BPCA and PREA
The Academy is continuing decades-long efforts to advocate for policies that promote safe and effective drugs for children. The AAP successfully advocated for the reauthorization of two vital pediatric drug laws this year, through which these laws were strengthened and made permanent.

On July 9, 2012, President Obama signed into law a bill to permanently reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  These reauthorizations were included as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).

The bill includes hard-fought pediatric provisions, negotiated after diligent advocacy by the Academy, including:

  • encouraging earlier pediatric study planning by drug manufacturers to ensure expedited pediatric drug information to patients and providers; 
  • giving the FDA new authority to ensure PREA requirements are met on time;
  • improving the transparency of data from pediatric studies conducted prior to 2007; 
  • making strides to prevent and address drug shortages; and 
  • increasing FDA expertise in neonatology and advancing drug studies in neonates.

Until BPCA and PREA were passed in 1997 and 2003 respectively, most medicines used to treat children had been tested for safety and efficacy only in adults. Under PREA, drug companies have been required to study adult drug indications in children, and the incentive under BPCA has been a successful mechanism to encourage drug companies to conduct pediatric studies requested by FDA—especially for off-label drug uses—in return for an additional six months of marketing exclusivity. BPCA and PREA have been enormously successful laws and have resulted in more than 500 drug labels revised with new pediatric information.

By making BPCA and PREA permanent, the law ensures that children will have a permanent seat at the table for drug research and development. The laws previously need to be reauthorized every five years and were scheduled to expire on September 30, 2012.

The bill also reauthorizes for five years an important BPCA program at the National Institutes of Health (NIH) that provides for pediatric studies of older drugs that no longer qualify for pediatric exclusivity, which can include some of the most commonly used drugs in children. In addition, the bill preserves the role of two FDA advisory committees in monitoring pediatric drug safety and advising the FDA on pediatric issues.

The FDA law ensures that children will have a permanent seat at the table for drug research and development.