21 U.S.C. § 379h–2 — Reauthorization; reporting requirements

(a) Performance report. Within 120 days after each fiscal year in which the FDA collects these fees, the Secretary must send a report to the House Energy and Commerce Committee and the Senate HELP Committee. The report covers two things. First, how well the FDA is meeting the goals set out in the letters tied to the 2022 Prescription Drug User Fee Amendments, the FDA's future plans for meeting them, and the status of the independent assessment described in those letters. Second, how well the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are doing on those goals and their future plans — broken down by review division, showing: the number of original standard and priority new drug and biologics license applications filed each year; the number of standard and priority efficacy supplements filed; the number of applications reviewed under accelerated approval, fast track, and orphan designation; the number of breakthrough designations; and the number of investigational new drug applications submitted. None of this requires the FDA to reveal information that other laws say must stay confidential. The report must also cover any earlier group ("cohort") of applications the FDA hasn't fully finished responding to yet. On top of the yearly report, the FDA must post fresh data every quarter — within 30 days after each quarter ends — on its website, both for that quarter and cumulatively for the year; the annual report can skip repeating data already posted this way. That quarterly data must include: the number and names of new draft and final guidance documents on drug-review topics, and whether each was legally required or promised in the PDUFA letters; the number and names of public meetings on review topics, similarly labeled; how many new drug and biologics license applications were approved and how many were filed; and, for fiscal years 2023 and 2024, when a sponsor asked for an in-person meeting and the FDA agreed one was appropriate, how many such meetings were requested and how many were actually granted, broken down by FDA center. The annual report must also explain the reasons behind changes in the PDUFA program. That means: data on how hiring has changed compared to what the 2022 letters promised, how many jobs are still vacant, and how many staff positions are funded by user fees versus regular budget money, broken down by division within CDER, CBER, the Office of Regulatory Affairs, and the Commissioner's office; data on how fee revenue and review costs have changed, including what's driving those changes and how the average cost per staff position has moved; for each of those four offices, how many employees do and don't have to track their time; and data on how the average staff hours needed to review each type of application has changed. Finally, each year's report must analyze: the gap between how many applications were filed and how many were approved, accounting for applications filed in one year but decided the next, and for how many applications missed their PDUFA review-time goals each year; whether CDER and CBER hit their performance-enhancement goals from the PDUFA letters; and the most common outside causes and trends that have made it hard for CDER, CBER, the Office of Regulatory Affairs, and the FDA overall to hit their review-time and performance goals. (b) Fiscal report. Within the same 120 days, the Secretary must also send those two committees a separate report — this one about how the FDA used its fee-charging authority and how it spent the fees collected that year. (c) Corrective action report. Each year, the Secretary must send a "corrective action" report to four committees: House Energy and Commerce, House Appropriations, Senate HELP, and Senate Appropriations. If the Secretary's analysis shows the FDA met all its PDUFA goals for the year, this report recommends ways to make the application-review process even better. If the FDA missed any goals, the report must explain in detail why, describe the situations and trends behind applications that missed their review-time goal or otherwise fell short, and — for missed performance-enhancement goals specifically — describe what the FDA is doing that year to do better. (d) Enhanced communication. Each year, if asked, FDA center staff must meet with staff from the Senate HELP and House Energy and Commerce Committees to go over what's in these reports. Each year, if asked, FDA representatives must also testify at a public hearing before those same two committees about these reports — and that hearing must happen within 120 days after the fiscal year ends. (e) Public availability. The FDA must post the reports required under parts (a) and (b) publicly on its website. (f) Reauthorization. Looking ahead to the five fiscal years after 2027, and to renewing this fee program for those years, the Secretary must work with Congress and outside groups. In developing recommended goals, the Secretary must consult the House Energy and Commerce Committee, the Senate HELP Committee, scientific and academic experts, health care professionals, patient and consumer advocacy groups, and the regulated drug industry. Before starting formal talks with the industry, the Secretary must: publish a notice in the Federal Register asking for public input; hold a public meeting where people can share their views, including suggested changes to the current goals; give the public 30 days after that meeting to send written comments; and post those comments on the FDA's website. While negotiating with industry, the Secretary must meet with patient and consumer advocacy groups at least once a month to hear their views and suggestions. The Secretary, working with industry input, must also give the two committees regular updates on how the negotiations are going. Once negotiations are done, the Secretary must: present the recommendations to Congress; publish them in the Federal Register; give the public 30 days to comment in writing; hold a public meeting for people to share their views; and revise the recommendations if needed based on all that input. By January 15, 2027, the Secretary must send Congress the final revised recommendations, a summary of the comments received, and an explanation of any changes made because of them. The Secretary must also post the minutes of every negotiation meeting with industry on the FDA's website, within 30 days of each meeting. Those minutes must describe, in enough detail, any real proposal either side made, and any major disagreements and how they were worked out.