§379j–53 Reauthorization; reporting requirements

Summary

The Secretary must send a report to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions within 120 days after each fiscal year ends. The report must say how the FDA is doing on the goals set in the letters in section 401(b) of the Biosimilar User Fee Amendments of 2022 and what the FDA plans to do next. It must cover any cohorts still waiting for complete responses, the number of original biosimilar applications filed and approved each year, and the number of resubmitted originals filed and approved. Every quarter, within 30 calendar days after the quarter ends, the FDA must post on its website the same data for that quarter and the year‑to‑date. The FDA must also post counts and titles of draft and final guidances and public meetings about biosimilar review, and say whether each was required by law or by the 401(b) letters. Beginning with fiscal year 2020, the annual report must include data and analysis on hires and vacancies agreed to in the 401(b) letters, the number of full‑time equivalents (FTEs) paid by fees and by budget authority for each of these parts of FDA (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and Office of the Commissioner), changes in fee revenue and costs and what drove those changes, changes in average cost per FTE, which employees must report time and which do not, and changes in average FTE hours to review each type of biosimilar application. Each year the Secretary must also send a report on how the fee authority was used and a corrective action report to the two congressional health committees and the House and Senate Appropriations Committees. If all goals were met, the corrective report must give ideas to make the review process better. If goals were not met, the report must explain why, describe the types of situations that caused missed goals, and list steps FDA is taking to do better. FDA staff must meet with the two congressional committees and, if asked, appear at a public hearing within 120 days after the fiscal year ends to discuss the reports. The annual reports must be posted on the FDA website. For planning the first five fiscal years after fiscal year 2027 and for reauthorizing these fees, the Secretary must consult the two congressional committees, experts, health professionals, patient and consumer groups, and industry. Before negotiating with industry, the Secretary must publish a Federal Register notice, hold a public meeting, allow 30 days for written comments, and post those comments. During negotiations, the Secretary must meet with patient and consumer groups at least monthly and give regular updates to the two committees. After talks, the Secretary must give recommendations to Congress, publish them in the Federal Register, allow 30 days for public comment, hold a public meeting, and revise recommendations as needed. The Secretary must send the revised recommendations and a summary of public views 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 any substantive proposals, major disagreements, and how they were resolved.