Congressional Hearing on FDA User Fees Tackles Issues Affecting Biosimilar Approvals


At a March 2, 2017, hearing of the Energy and Commerce Committee on the FDA’s Generic Drug User Fee (GDUFA) and Biosimilar User Fee (BsUFA) programs, stakeholders in industry and government regulatory agencies in the biosimilar and generic drug space agreed that both programs should be reauthorized before they expire at the end of September because of their importance in accelerating the review and approval of generic and biosimilar drugs. Both user fee programs authorize the FDA to collect fees from drug manufacturers to fund timely reviews and approvals of new generics and biosimilars. The recently unveiled fiscal year 2018 federal budget calls for doubling FDA user fees to ensure that pharma “pay for their share” in a tightened budgetary environment. The drug and device industries had recently completed user fee agreements with the FDA, having agreed upon appropriate amounts of industry fees to support needed FDA improvements.

Witnesses at the hearing included Janet Woodcock, MD, director of the Center for Drug Evaluation and Research (CDER); Juliana Reed, immediate past president of the Biosimilars Forum; Bruce A. Leicher, president of the Biosimilars Council; Kay Holcombe, senior vice president of Science Policy, Biotechnology Industry Organization; and David Gaugh, senior vice president of Sciences and Regulatory Sciences of the Association for Accessible Medicines (formerly GPhA).

While the focus of the hearing was on the role and importance of user fees, members of the congressional committee brought up topics ranging from rising US drug prices, President Donald J.Trump’s executive order requiring the elimination of 2 federal regulations for each new regulation enacted, and the proposed government hiring freeze and its effect on the drug approval process. An important theme of the hearing was timeliness, with many questions concerning how the FDA plans to decrease review times and increase first-cycle generic approvals. Only 9% of generic drugs are approved in the first review cycle, even after the 2012 authorization of GDUFA. New pharmaceuticals, by contrast, are primarily approved in the first review cycle, and there have only been four biosimilars approved to date.

Bruce Leicher, who is also vice president and general counsel of Momenta, testified that if renewed, BsUFA II promises the release of new guidances, more industry/agency meetings, better resource planning, and new hires at FDA for biosimilar drug reviews. Leicher noted that during BsUFA II and GDUFA II negotiations last year, the industry had called for more FDA staff to encourage quicker reviews and a more reliable meeting schedule, and more transparency on how user fees were being spent by the FDA. These elements are all part of the renewed BsUFA and GDUFA programs awaiting reapproval, and are key to improving communication between the FDA and the biosimilar sponsors so that sponsors get necessary developmental information early and can make any corrections before filing for approval.

BsUFA II, it was noted, will adopt the Prescription Drug User Fee Act’s program review model, which establishes communication timelines and opportunities to discuss any developmental issues that can potentially prevent approval of the biosimilar application.

At several points in the hearing, speakers brought up their concerns about achieving the goals of BsUFA II should an FDA hiring freeze come to pass. The FDA has already experienced challenges hiring staff over the last 5 to 6 years, which is affecting review times. The hiring freeze will likely cause issues in recruiting additional staff to review biosimilars, Woodcock emphasized. These hiring problems will affect the approval of more cost-effective drugs for Americans.

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