WASHINGTON, DC – U.S. Senator Jack Reed’s legislation to make children’s medications safer has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee.   

The Better Pharmaceuticals and Devices for Children Act (BPDCA), which will help ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children, received unanimous support and was included as part of a bill to reauthorize the Food and Drug Administration’s (FDA) user fees.

Reed’s bill, which is cosponsored by Senators Lamar Alexander (R-TN), Patty Murray (D-WA), and Pat Roberts (R-KS), ensures 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 legislation is critical for children’s health.  Medications work differently in infants, children, and teenagers than they do in adults.  We want parents to know that the medicine they give their kids is safe and effective.  This legislation will ensure that medications and medical devices continue to be tested for use in kids and will provide important information to guide clinical care for children,” said Reed.  “I commend my colleagues, particularly Senator Alexander, Senator Murray, Senator Roberts, and Chairman Tom Harkin (D-IA) for their leadership and commitment to making children’s health a national priority.”

Congress passed legislation mandating the testing of pharmaceutical drugs in the 1960s, but the law did not apply to children’s medications.  In 1997, Congress passed the Best Pharmaceuticals for Children Act (BPCA), which acknowledged the importance of ensuring medications were effective and safe for children by providing an incentive for pharmaceutical companies to invest in pediatric research.  Not until 2003, with the passage of the Pediatric Research Equity Act (PREA), did Congress begin requiring pharmaceutical companies to engage in these studies.  Since the enactment of these laws, 426 drug labels have been revised with important pediatric information and there has been a decline in the number of drugs used “off-label” in children from 80 to 50 percent.     

In 2007, a complementary initiative was enacted to promote the development of pediatric medical devices, which can lag five to 10 years behind those manufactured for adults, the Pediatric Medical Device Safety and Improvement Act.  This law has resulted in a five-fold increase in the number of small-market medical devices designated for pediatric use. 

However, these laws will expire on October 1st unless Congress passes legislation to renew them.

The Better Pharmaceuticals and Devices for Children Act would make permanent these critical laws, with 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.

Now that the bill has been approved by the HELP Committee, it must be passed by the full Senate.  The U.S. House of Representatives is also working on a bill that would permanently reauthorize the pediatric programs.