• Analysis or Summary
  • July 9, 2012

The Food and Drug Administration Safety and Innovation Act (FDA-SIA) - Overview and Key Provisions

S. 3187, The Food and Drug Administration Safety and Innovation Act (FDA-SIA), legislation to reauthorize industry user fees that fund FDA drug and device reviews, was signed into law by President Obama on July 9, 2012. The legislation was approved by the House and Senate with overwhelming bipartisan majorities. 

Throughout the months-long legislative process leading up to passage, children’s hospitals worked to secure the inclusion of legislative language in a number of priority areas such as drug shortages and pediatric research. Advocacy by children’s hospitals included delivering testimony at congressional hearings, submitting written comments on legislative proposals both as an Association and in coalitions, and meeting directly with congressional staff charged with drafting the legislation. As a result, the new law addresses many of the priority areas identified by children’s hospitals and its passage is a major success for children’s health, children’s hospitals and the Association.

Key Victories for Children in the FDA-SIA 

In addition to reauthorizing drug and device user fees that help fund the FDA, this comprehensive law includes numerous provisions dedicated to improving pediatric medicine.

  • Permanent extension of two critical drug laws for kids: The Best Pharmaceuticals for Children Act (BPCA) and The Pediatric Research Equity Act (PREA). The FDA-SIA not only permanently extends the programs, but also makes policy improvements proposed by children’s advocates on neonates and transparency. BPCA and PREA incentivize pediatric research, increase drug safety and efficacy information available to pediatricians and reduce off-label drug use in children.
  • Drug Shortages. The FDA-SIA takes significant steps toward alleviating the record-number of drug shortages threatening patient care and skyrocketing drug costs in recent years. In addition to instituting an early-warning notice system to give providers six months of advance notice ahead of shortages, the law creates an FDA Task Force charged with creating a strategic plan to enhance FDA’s ability to prevent and mitigate shortages. Additionally, hospitals will now be allowed to repackage drugs in short supply into smaller amounts and transfer them to hospitals within the same health system, even if that hospital is in a separate building. This is key for children’s hospitals, since pediatric-doses of drugs are often first to go into shortage and may be available in larger quantities at adult hospitals within the same system.
  • Controlled Substances Shortages. The legislation eliminates regulatory barriers that impede efforts to alleviate shortages of medications made with controlled substances, such as Ritalin, that are commonly used in children’s hospitals for children with attention-deficit disorder, seizures and autism. The Attorney General will now be required to publicly respond to requests to increase manufacturing limits within 30 days.
  • Antibiotic Resistance. The FDA-SIA includes an incentive for drug manufacturers to develop drugs that will fight the growing public health threat of antibiotic-resistant pathogens, such as MRSA.
  • Orphan Drugs. Called the “Rare Pediatric Disease Voucher Incentive,” this provision encourages drug manufacturers to develop drugs that prevent/treat conditions that affect small populations of children.

Association Contact: Jenny Rudisill (202) 753-5340