“Better Pharmaceuticals for Children Act,” Which Improved Pharmaceutical and Device Use for Children, Was Included in the Food and Drug Administration Safety and Improvement Act (FDASIA)
WASHINGTON, D.C.—U.S. Senators Tom Harkin (D-IA), Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA), and Pat Roberts (R-KS) today released the following statement applauding the news that the 500th drug has been labeled with pediatric information as a result of provisions included in the Food and Drug Administration Safety and Innovation Act (FDASIA). Senators Reed, Alexander, Murray, and Roberts were sponsors of the Better Pharmaceuticals and Devices for Children Act, which was included in FDASIA; Harkin, who is Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led Senate passage of FDASIA, which was enacted in July 2012.
“Children often respond to medications very differently than adults do—which is why stronger research into pediatric pharmaceutical and device use is so important. Pediatric drug labeling gives doctors and families the important information they need to make safe and informed decisions,” Chairman Harkin said. “The news of the 500th drug labeled with pediatric information by the FDA marks a major milestone for children’s health and a clear example of the progress we can achieve by working together.”
“This is an important milestone. It shows the FDA is making real progress ensuring the safety and effectiveness of children’s medicine. Ultimately it is about improving health outcomes for children and their families,” said Senator Reed, who authored the Better Pharmaceuticals and Devices for Children Act. “Thanks to this law, the FDA approval process includes comprehensive research on how certain medications should be used in kids and provides important information to guide clinical care for children.”
“Drugs don’t have the same effect on a child that they do on an adult, and putting pediatric labels on these drugs allows doctors to avoid dangerous guesswork in prescribing medicine for children,” said Senator Lamar Alexander, Ranking Member of the Senate HELP Committee.
“Today’s news that 500 drugs are now labeled with children’s safety information proves that this bipartisan legislation is working, and it shows, once again, that we can take commonsense steps to make medicines safer,” said Senator Murray. “We know that children have their own, specific medical needs and often react to medications differently than adults, but with improved public information and continued research, we can help ensure that children receive the medicines they need.”
"This is an important milestone that proves the program is working. Parents can be reassured drugs and their labeling have been tested and are appropriate for their children, and that peace of mind is invaluable,” Senator Roberts said.
“Thanks to the work of Senators Harkin, Reed, Alexander, Murray, and Roberts, we now have 500 drug labels that include important 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,” said American Academy of Pediatrics President Thomas K. McInerny, MD, FAAP.
The Better Pharmaceuticals and Devices for Children Act, included in FDASIA, made permanent the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), two laws that encourage and require the study of drugs in children. The FDASIA law also included a number of other important pediatric drug provisions, including requiring earlier and better pediatric study planning for drug companies; granting FDA new tools to ensure the timely submission of pediatric data; increasing the focus on neonatal drug studies; increasing and improving transparency and accountability; requiring a final rule on pediatric device tracking; and reauthorizing the pediatric device consortia.