On April 28, CHA, in conjunction with allied provider and disease groups, sent a letter to House and Senate leadership within the Energy and Commerce Committee and the Health, Education, Labor and Pensions (HELP) Committee. The letter urged lawmakers to include policies that improve the study and labeling of drugs used in children within the Food and Drug Administration Reauthorization Act of 2017 (FDARA).
- Remove the orphan drug exemption in the Pediatric Research Equity Act (PREA)
- Allow PREA to apply to targeted therapies
- Improve accountability
- Ensure earlier pediatric study planning for deadly diseases
- Increase transparency
- Reauthorize and make permanent the Best Pharmaceuticals for Children Act (BPCA) Program within the National Institutes of Health
- Promote studies in neonates
The Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee are expected to markup the package later this month.