§379h–2 Reauthorization; reporting requirements

Summary

Requires the Food and Drug Administration (FDA) to write and send a yearly report, within 120 days after each fiscal year ends, to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee. The report must say how the FDA is doing on the goals set in the Prescription Drug User Fee Amendments of 2022 and show plans to meet them. It must give detailed counts by review division for many types of drug and biologic filings and actions (for example, original standard and priority applications, efficacy supplements, accelerated approval, fast track, orphan and breakthrough designations, and investigational new drug applications). The report must also cover earlier groups of applications that are still unfinished, staffing and vacancy numbers, how many full‑time equivalent (FTE) positions are paid with fees versus budget authority, changes in fee revenue and costs, time needed to review each application type, and analysis about filings versus approvals and reasons goals were or were not met. The FDA must post certain data on its website quarterly (within 30 days after each quarter) and cumulative for the fiscal year, including guidances, public meetings, numbers of filings and approvals, and for fiscal years 2023 and 2024 information about in‑person meeting requests and approvals. Each year the FDA must also send a report about how fee authority was used and a corrective action report to both the House Energy and Commerce and Appropriations Committees and the Senate HELP and Appropriations Committees; if goals were met the corrective report should recommend improvements, and if goals were missed it must explain why and list steps being taken to fix problems. FDA representatives must meet with and, if requested, testify before those Congressional committees (including a public hearing within 120 days after the fiscal year ends). For reauthorizing the fee program and setting goals for the first five fiscal years after 2027, the Secretary must consult with the two Congressional committees, experts, health professionals, patient and consumer groups, and industry. Before negotiating with industry, the FDA must publish a Federal Register notice, hold a public meeting, accept 30 days of written comments, and post those comments. During negotiations the FDA must meet at least monthly with patient and consumer groups, give regular updates to the two Congressional committees, and after negotiations publish recommendations, allow 30 days for public comment and a public meeting, revise recommendations as needed, and send final revised recommendations and a summary of public comments to Congress by January 15, 2027. The FDA must put the annual reports, the fee‑use report, and negotiation meeting minutes on its website (minutes posted within 30 days and summarizing proposals and major disagreements).