5/24/2012 — 

WASHINGTON, DC – U.S. Senator Jack Reed’s (D-RI) legislation to help make children’s medications and medical devices safer was passed today by the full Senate.  

Reed wrote the Better Pharmaceuticals and Devices for Children Act (BPDCA) to help ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children.

Reed’s bipartisan 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, dosage, and any side effects of medications for children, or if the drugs are not recommended for use in children.

“We want parents to know that the medicine they give their kids is safe and effective.  This legislation takes critical steps to do just that.  It will help spur pediatric drug research and provide important clinical information to guide doctors in their care for children,” said Reed. 

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, 427 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 46 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 were set to expire on October 1st without this 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. 

•           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.

Reed’s bill was included as a key part of the FDA Safety and Innovation Act.  Now that the bill has been passed by the full Senate, it must be reconciled with the version that the U.S. House of Representatives is working on before it can be signed into law.