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Regulatory News | 09 May 2017 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act.
Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."
The science board, ahead of FDA’s submission of the work plan to Congress, was asked to focus on two questions: "Are the criteria used by FDA to prioritize the proposed allocation of funds appropriate? Are the proposed activities reasonably likely to contribute to successful achievement of the Cures Act requirements?"
The conversation among the science board and FDA officials bounced between provisions of the new law, with general agreement that the plan was feasible.Mark McLellan, PhD, chair of the science board, and Lynn Goldman, MD, MPH, dean of the Milken Institute School of Public Health at George Washington University, said they are confident that the criteria seem reasonable.
On the use of real world evidence by FDA, there seemed to be some consensus that the use of such data would help the agency in certain cases.
Cynthia Afshari, PhD, VP at Amgen, stressed the need for a sustainable plan directed at the "most innovative approaches to bring the value back to the patient."
The hot topic of drug pricing, which is likely to see a Senate committee hearing sometime soon, was also brought up.
Laura Tosi, MD, Director of the Bone Health Program at Children’s National Medical Center in Washington, DC, said: "Rare disease drugs have become a big deal and some of the prices charged are mind boggling. Is there anything under this to increase competition between the drugmakers? What authority is there to say: Guys, you can’t go crazy."
Several FDA officials responded, noting some of the incentives afforded by orphan products though basically telling the board that drug prices are outside the purview of FDA.
Others seemed to get bogged down by the details of the new law and what the new provisions would change at the agency, while some were interested in hearing what the new funds would generate for the agency.
Theodore Reiss, MD, head of clinical research and development in inflammation and immunology at Celgene, added: "Overall, the work plan is excellent, right on the money, and appropriate for the limitations that the agency has…but a lot of focus is on guidance development, and appropriately so, but I was looking for more on how FDA is helping to generate new knowledge and not just criteria, via collaborative efforts or other mechanisms."
2017 Meeting Materials, Science Board to the FDA
Tags: FDA science board, Celgene, GSK, Amgen, 21st Century Cures