(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA) announced that legislation she wrote with Senators Jack Reed (D-RI), Lamar Alexander (R-TN), and Pat Roberts (R-KS) to improve the safety of children’s medications and medical devices has passed through the full Senate Health, Education, Labor and Pensions Committee (HELP). The bipartisan legislation, the Better Pharmaceuticals and Devices for Children Act (BPDCA), was included in the FDA Safety and Innovation Act.
The language will help ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children. It will ensure that children are prioritized in the drug development process and that drug labels provide clear, detailed information about the proper use and dosage of medications for children.
“This language will push to make sure that children are never an afterthought when it comes to the safety and effectiveness of our nation’s drugs and medical devices,” said Senator Patty Murray. “I was proud to work with Senators Reed, Alexander, and Roberts on this bipartisan effort to make common-sense changes that will give doctors and parents more information and help children get the safe and effective care they deserve. I want to thank Chairman Harkin and Ranking Member Enzi for including our bill in the manager’s package and helping to move it through the committee today.”
The BPDCA language would reauthorize several key federal programs to protect children, and make the following improvements:
Ensuring pediatric studies are planned earlier in the drug development process. Currently, pediatric study plans can be submitted to the FDA when a company submits its drug application. This can lead to insufficient and inappropriate study plans and delays of important pediatric data. BPDCA would require the submission of a pediatric study plan at the end of phase 2 in the drug development process, which is consistent with the precursor to PREA, the Pediatric Rule.
Ensuring pediatric studies are completed. PREA studies can be waived or deferred to a later time post-market. Unfortunately, in studies due after September 27, 2007, an alarming 78 percent are currently late or were submitted late. BPDCA would give FDA the authority to distinguish between reasonable and unreasonable delays and have enforcement tools to ensure required pediatric studies are completed.
Increasing transparency of completed, pending, and declined studies in children. Written requirements submitted to FDA prior to 2007 were not made public. This information may be critical to researchers, as well as clinicians who can’t rely on updated labels. BPDCA would make written requests public that were issued between 2002 and 2007.
Continuing the success of the pediatric medical device incentive and pediatric device consortia initiative. The pediatric profit allowance for Humanitarian Use Devices has proven to be an effective incentive for the development of new pediatric medical devices that are designed specifically for the needs of children. In just two and a half years, the Pediatric Device Consortia assisted in advancing the development of 135 proposed pediatric medical devices, which has helped get life-saving and life-improving pediatric devices to the patients that need them. BPDCA would continue these important advancements.