Lawmakers’ bipartisan bill included in FDA User Fee Act package
WASHINGTON, D.C. – Representatives Edward J. Markey (D-Mass.), Anna G. Eshoo (D-Calif.) and Mike Rogers (R-Mich.) today hailed inclusion of their legislation to reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) in the FDA User Fee Act package that unanimously passed the House Energy and Commerce Committee. Because of these laws, in the past five years alone at least 130 medications have been studied for use in children. The legislation has been successfully expanding the number of treatment options for children since Congress first recognized the need to ensure that drugs were being studied in children and passed BPCA in 1997. The Journal of the American Medical Association published data earlier this week showing that, because of these two laws, 46 percent of products used in children now have pediatric information on their labels, compared with just 22 percent back in 1985. The bipartisan reauthorization of BPCA and PREA makes significant improvements to the laws to increase the number of studied medications available for children that would help reduce incidences of wrong dosage or age and size-appropriate treatment.
“Doctors should never have to guess when it comes to prescribing the appropriate amount of medication for a child. Yet for too long, improving our understanding of how drugs impact children has been relegated to the kid’s table,” said Rep. Markey. “I am proud to have worked with my colleagues Reps. Eshoo and Rogers on these important bills that will address the lack of parity that still exists between what we know about the impact of drugs on children and newborns versus adults. This legislation provides doctors and patients with vital information about the appropriate use, dosage, and side effects of pediatric drugs so that children can take their medication safely.”
“I’m thrilled by the Committee’s vote today,” said Rep. Eshoo. “Doctors should not have to play a guessing game when it comes to prescribing medication to children. That’s why I’ve been working for more than a decade to make progress in pediatric drug labeling. Kids deserve access to the same safe medicines adults have, and today we’re one step closer to that goal.”
“Studying and testing pediatric prescription drugs is an expensive and scientifically challenging task, which too often places children at risk of exposure to ineffective or harmful treatments,” said Rep. Rogers. “Creating a more certain regulatory environment for drug manufacturers, physicians, patients, and the FDA in pediatric drug research will help to overcome the inherent challenges in developing new medicines for children.”
The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act:
Provides FDA the necessary enforcement tools to ensure that companies complete their required pediatric studies under PREA on time.
Increases transparency of the status of pediatric clinical trials required under PREA.
Ensures the timely submission of a company’s “Pediatric Study Plan”, a blueprint for how a company plans to study their drug in children.
Ensures that neonatologists are involved in the process of reviewing and planning pediatric clinical trials.