H. R. 1262
February 12, 2025
Mr. McCaul (for himself, Mr. Bilirakis, Mrs. Dingell, Ms. Schrier, Mrs. Harshbarger, Ms. Matsui, Mr. Crenshaw, Ms. Castor of Florida, Mr. Kelly of Pennsylvania, Mrs. Trahan, and Mr. Weber of Texas) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
1. Short title; table of contents; 2. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs; 3. Ensuring completion of pediatric study requirements; 4. FDA report on PREA enforcement; 5. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases; 6. Limitations on exclusive approval or licensure of orphan drugs; 7. Program for pediatric studies of drugs; 8. Organ Procurement and Transplantation Network; 9. Establishment of Abraham Accords Office within Food and Drug Administration
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,