§379j–53 Reauthorization; Reporting Requirements

Summary

The Secretary must send a yearly report within 120 days after the end of each fiscal year to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions. The report must say how the Food and Drug Administration (FDA) is doing on the goals set in the Biosimilar User Fee Amendments of 2022. It must cover any earlier groups of biosimilar applications that still do not have a complete FDA response. The report must show how many original and resubmitted biosimilar applications were filed each year and how many were approved. It must also include staffing and budget details (starting with fiscal year 2020) for 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: how many people were hired, how many vacancies remain, how many full‑time equivalents were paid by fees versus by the regular budget, and how many employees must report time. The FDA must give data and analysis on fee revenue and review costs, average cost per full‑time equivalent, and the average work hours needed to finish each type of review. Each year the report must analyze the gap between applications filed and approvals issued, explain whether review goals were missed (including when decisions are delayed into the next year), show if the centers met their performance goals, and describe common outside causes or trends that affected meeting review times. The Secretary must also file a separate annual report on how fee authority was used and submit a corrective action report to Congress: if goals were met, the report should recommend improvements; if not met, it must explain why and list steps FDA is taking to do better. FDA must post the annual reports publicly on its website. Every fiscal quarter, within 30 calendar days after the quarter ends, the Secretary must post quarterly and year‑to‑date data on the FDA website. That quarterly data must include numbers and titles of draft and final guidances and public meetings about biosimilar review and say whether they were required by law or promised under the 2022 letters. When planning goals and reauthorization for the five fiscal years after fiscal year 2027, the Secretary must consult with the two congressional committees above, scientific and academic experts, health care professionals, patient and consumer groups, and industry. Before negotiating reauthorization with industry, the Secretary must publish a Federal Register notice, hold a public meeting, allow 30 days after the meeting for written comments, and publish those comments on FDA’s website. During negotiations, the Secretary must meet at least once a month with patient and consumer groups and give regular updates to the two committees. After negotiations, the Secretary must publish recommendations in the Federal Register, allow 30 days for public written comments, hold a public meeting, consider comments, and revise recommendations as needed. The Secretary must send the revised recommendations and a summary of comments to Congress by January 15, 2027. Minutes of each negotiation meeting with industry must be posted on the FDA website within 30 days and must summarize proposals and any major disagreements and how they were resolved.