Lebovitz, Yeonwoo, English, Rebecca, Claiborne, Anne. "4 Barriers to Enhanced Regulatory Science." Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press, 2011.
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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary
FIGURE 4-1 Breadth of FDA responsibilities by number of establishments as of 2007.
SOURCE: FDA, 2007.
2010e, 2010f). According to FDA, “[i]n the past five years, the number of FDA agreements with its regulatory counterparts throughout the world more than doubled and it continues to grow. FDA has over 100 formal agreements with its counterparts in 29 countries, 18 with the European Commission or its European Union members, and two with the World Health Organization.” In addition, FDA established an office in China as of 2008, and has planned locations in India, Europe, Latin America, and the Middle East (FDA, 2010f). While user fees, such as those allowed by the Prescription Drug User Fee Act, can help support product review, user fees are restrictive, present conflict-of-interest issues, and are viewed with suspicion by the public, according to Cassell.
Since the FDA Science Board report was published, FDA has received limited increases in funding, yet its budget still pales in comparison with the funds allocated to similarly sized agencies. For example, FDA shared a similar budget and workforce as the Centers for Disease Control and Prevention (CDC) approximately 25 years ago (Grossman, 2010). As of 2009, however, CDC’s total budget is more than three times the size of FDA’s, and CDC holds approximately 4,000 more employees (CDC, 2009).
While money is not the sole problem, said Cassell, having sufficient funds is necessary to begin addressing other issues. The agency still needs a sustainable source of funding to gain autonomy and to ensure continuity of its operations.