Under the Pediatric Research Equity Act (PREA), what can the FDA require of a drug company?

Under the Pediatric Research Equity Act (PREA), what can the FDA require of a drug company?

• A. The FDA can require pediatric drug trials.
• B. The FDA funds pediatric trials.
• C. The FDA cannot require trials; only BPCA can.
• D. The FDA extends market exclusivity for pediatric studies.

Answer: (A)

PREA gives the FDA authority to require sponsors to study a drug in children when there is a new active ingredient, new indication, or new dosage form. The purpose is to gather safety and efficacy data in pediatric patients and to ensure labeling provides appropriate dosing and usage information for children. Trials can be mandated as a condition of approval, with possible waivers or deferrals in specific situations, but the default is that pediatric studies are required. The FDA does not fund these trials—that responsibility lies with the sponsor. Extending market exclusivity for pediatric studies is not a PREA provision; that incentive comes from BPCA, a different program aimed at encouraging pediatric research.

PREA gives the FDA authority to require sponsors to study a drug in children when there is a new active ingredient, new indication, or new dosage form. The purpose is to gather safety and efficacy data in pediatric patients and to ensure labeling provides appropriate dosing and usage information for children. Trials can be mandated as a condition of approval, with possible waivers or deferrals in specific situations, but the default is that pediatric studies are required. The FDA does not fund these trials—that responsibility lies with the sponsor. Extending market exclusivity for pediatric studies is not a PREA provision; that incentive comes from BPCA, a different program aimed at encouraging pediatric research.