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FDA's Director of Drug Evaluation Urges Congress to Pass the BsUFA Reauthorization


Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation (CDER), urged members of Congress to pass the reauthorizations of the Biosimilar User Fee Act (BsUFA) and the Generic Drug User Fee Act (GDUFA). Woodcock testified before the House Energy and Commerce Committee on March 2, 2017.

Congress has already agreed upon details of the reauthorizations, but they need to be finalized before the end of September 2017 for the FDA to continue receiving funding to ensure timely review of biosimilars and generics over the next 5 years. “Many of our most important drugs are biological products,” Woodstock said. “It is important for the public health of the US population to have access to safe, effective, and affordable biological products. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs, enabling greater access for more patients.” According to Woodcock, 64 biosimilars in development are expected to provide competition for 23 biologics.

Rigorous review and approval standards are essential to earn physicians’ and patients’ confidence in biosimilar and interchangeable products, Woodcock explained, and they are key to the success of the biosimilar program. The FDA cannot achieve these goals without adequate funding in place.

While FDA has made significant progress in creating and implementing the biosimilar program, there is more work to do and challenges that must be addressed, Woodcock said. The ability to hire the right staff is key to ensuring timely review of new biosimilars, and the agency is committed to recruit and retain the critical scientific, technical, and professional talent needed to address complex and often novel scientific and legal issues involved in biosimilar review, she added. But the lack of additional staffing to handle the increased workload for biosimilar review has affected review performance, she told members of Congress. For example, in 2015, the FDA was able to schedule only 50% of initial advisory meetings within the 90-day meeting goal. While 2016 saw an improvement, the agency continued to face challenges and was unable to meet some performance goals.

In the FDA’s discussions with industry, biosimilar producers said they would like to see more meetings and faster turnaround of Agency advice in the reauthorized BsUFA. “BsUFA I provided critically needed funding for FDA to implement the beginning of a successful biosimilars program,” said Woodcock. “BsUFA II will allow the FDA to continue building this program and make improvements where needed.” She said the new pathway for biosimilar and interchangeable products has the potential to offer a significant contribution to the public health of many Americans by increasing access to more affordable biologics. “At FDA, we are working hard to ensure this positive impact can be realized,” she concluded. “We are optimistic and energized about the future of biosimilars.”

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