21 U.S.C. § 379j–53 — Reauthorization; reporting requirements

(a) Performance report. (1) Within 120 days after each fiscal year in which the FDA collects biosimilar user fees, the Secretary must report to the House Energy and Commerce Committee and the Senate HELP Committee on the FDA's progress toward the goals in the Biosimilar User Fee Amendments of 2022 commitment letters, and its future plans for meeting them. The report must cover every earlier "cohort" of applications the FDA has not yet finished giving a complete response to. (2) The report must also include: information on those unfinished cohorts again; how many original biosimilar applications were filed each year and how many were approved; and how many resubmitted original applications were filed each year and how many approval letters were issued for them. (3) Within 30 days after each fiscal quarter, the FDA must post — for that quarter and cumulatively for the year — the same two kinds of data required for generic drugs: the number and titles of biosimilar-related draft and final guidance documents, and of public meetings, noting each time whether it was legally required or a commitment-letter promise. The FDA may skip repeating this in the annual report. (4) Starting with fiscal year 2020, the annual report must also include: hiring and vacancy numbers against the commitment letters' targets, and staff counts funded by biosimilar fees versus the FDA's regular budget, broken down by the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; changes in fee revenue and review costs and their causes, including changes in the average cost per staff member; the number of employees required, and not required, to track their time in each of those four offices; and changes in the average staff hours needed to review each type of biosimilar application. (5) Each year's report must analyze: the gap between biosimilar applications and supplements filed versus approvals issued, accounting for applications filed late in the year that won't be decided until the next one, and applications that missed the commitment letters' goals; whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research met their performance goals; and the most common causes of missed review-time or performance goals. (b) Fiscal report. Within the same 120 days, the Secretary must separately report to those same two committees on how the fee authority was used and how the fees were spent. (c) Corrective action report. Each fee-collecting year, the Secretary must send a corrective action report to House Energy and Commerce, House Appropriations, Senate HELP, and Senate Appropriations. If the analysis under (a)(5) shows every goal was met, the report must recommend ways to improve and speed up the biosimilar application review process. For any goal that was missed, the report must give a justification and describe the circumstances behind missed review-time or performance goals — including applications later approved on first review — and, for missed performance goals, describe what the FDA is doing that year to do better. (d) Enhanced communication. Each year, when asked, FDA staff with drug-review expertise must meet with the Senate HELP and House Energy and Commerce Committees to go over the reports. Also when asked, FDA representatives must testify at a public hearing before those same two committees, and that hearing must happen within 120 days after the fiscal year ends. (e) Public availability. The FDA must post the reports required under (a) and (b) on its website for the public. (f) Reauthorization. In preparing recommendations to Congress on the goals and plans for the first five fiscal years after 2027, and on renewing this fee program for those years, the Secretary must consult six groups: 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 industry. Before starting to negotiate with the regulated industry on renewal, the Secretary must: publish a Federal Register notice asking for public input; hold a public meeting where people can share their views; leave 30 days after that meeting for written public comments; and post the comments on the FDA's website. At least once a month during the industry negotiations, the Secretary must talk with patient and consumer advocacy groups about their views and suggestions. The Secretary must also give the Senate HELP and House Energy and Commerce Committees regular updates on the negotiations, in consultation with industry. After negotiating with industry, the Secretary must present the resulting recommendations to those two committees, publish them in the Federal Register, allow 30 days for public written comments, hold a meeting on them, and revise them as needed based on the public's views and comments. By January 15, 2027, the Secretary must send Congress the final revised recommendations, a summary of the comments received, and any changes made because of them. Within 30 days after each negotiation meeting between the FDA and the regulated industry, the FDA must post the meeting minutes on its website. Those minutes must describe, in enough detail, every substantive proposal either side made and any significant disagreements and how they were resolved.