Eshoo, Rogers Celebrate Pediatric Drug Milestone

WASHINGTON, D.C.—Reps. Anna G. Eshoo (D-Calif.) and Mike Rogers (R-Mich.) issued the following statements to celebrate the 500th pharmaceutical drug labeled with pediatric information as part of implementation of the Food and Drug Administration Safety and Improvement Act (FDASIA). Eshoo and Rogers are longtime champions of pediatric drug safety. In 2012, they authored the reauthorization of legislation included in FDASIA, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which have contributed to increased pediatric labeling on pharmaceutical drugs to ensure proper dosage and reduce harmful side effects in children. The two laws also incent pharmaceutical companies to conduct more studies on how medications affect children.

“The 500th pharmaceutical drug with pediatric labeling is a major milestone,” Rep. Eshoo said. “With more ubiquitous use of pediatric labeling by pharmaceutical companies, parents can be increasingly confident that their children are getting the most effective and proper dosage of treatments to protect them from harmful side effects and unnecessary risks.”

“I am proud to have been a part of such important legislation that has now achieved 500 drug labels,” Rep. Rogers said. “It is very difficult to study and test prescription drugs for children, placing them at incredible risk of harm, which is why the permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) that was signed into law last year continues to be such a vital piece of improving prescription drugs for children.”

“Children are not just small adults; their unique developmental and physiological needs affect how medications work for them,” said AAP President Thomas K. McInerny, MD, FAAP. “We now have 500 drug labels that include new information for children, which has not only revolutionized pediatric practice, but has also helped provide children with access to safe and effective medicines labeled especially for them. Pediatricians owe an enormous debt of thanks to Congressman Rogers and Congresswoman Eshoo for their tireless advocacy to make sure children can access the medicines they need when they need them.”

Background:

Congress first recognized the need to ensure that drugs were being studied in children in 1997 when it passed Eshoo's legislation, BPCA, a bill to incent the study of off-label uses in pediatric populations by offering companies an additional six months of patent life on their product. In 2003, Congress passed another of Eshoo's bills, PREA, to study on-label indications in children, when safe and appropriate.

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