Senators Seek to Improve Safety of Children's Medications and Medical Devices

Posted on April 17, 2012

WASHINGTON, DC – In an effort to make medications safer for children, U.S. Senators Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA), and Pat Roberts (R-KS) today introduced the bipartisan Better Pharmaceuticals and Devices for Children Act (BPDCA).  The legislation will help ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children.  The legislation 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.

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.

“This legislation is critical for children’s health.  Drugs work differently in infants, children, and teenagers than they do in adults.  There are hundreds of medications out there aimed at children.  We want parents to know that the medicine they give their kids is safe and effective,” said Senator Jack Reed.  “This legislation will ensure that drugs and medical devices continue to be tested for use in kids and will provide important information to guide clinical care for children.”

“This bill will strengthen successful programs that have helped speed the design of life-saving medical devices for children, and enabled doctors to avoid dangerous guesswork in prescribing medicine for children,” said Senator Lamar Alexander.

“This bill 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.”

“Parents want nothing more than to make their children feel better when they’re sick,” said Senator Pat Roberts.  “I am pleased to be on board with this common sense bill that provides parents with the assurance that the medicines their kids are taking are reliable, safe and appropriate.  It is critical that these drugs and medical devices are properly tested, and I am grateful this bill provides certainty and reliability for the future of children’s products and treatments.”

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.

The Reed-Alexander-Murray-Roberts bill is expected to be considered by the Senate Health, Education, Labor and Pensions (HELP) Committee later this month.