At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health. The Obama administration has mandated the development of these countermeasures, and FDA will contribute to the initiative in three ways, Hamburg said.
First, the agency will foster enhanced review and novel manufacturing approaches for medical countermeasures of the highest priority. From the development process onward, FDA will collaborate with developers and government partners to define viable regulatory pathways. The collaboration will aim to anticipate and resolve bottlenecks and to identify and resolve scientific problems, thus speeding drugs’ progress toward product approval.
Second, FDA will work with government agencies, including the US Department of Health and Human Services, to examine the legal framework, including regulatory and policy approaches, for developing medical countermeasure and making them available. The agencies will assess the adequacy of this framework and identify improvements that could support preparedness and response to public-health threats.
Third, the agency will try to advance regulatory science and improve the development and evaluation of countermeasures by strengthening FDA’s own scientific capacity and establishing partnerships with government, industry, and academia. Scientific opportunities are “outstripping our ability to translate new discoveries and opportunities into new products,” said Hamburg. Advancing regulatory science will help develop new ways to evaluate product efficacy, flexible approaches to product development and manufacturing, new methods to improve product stability, and new statistical approaches to assessing efficacy with limited data, she added.
Hamburg cited a meningococcal A conjugate vaccine as an example of how FDA has used regulatory science to encourage product development and speed authorization. FDA scientists developed technology to increase vaccines’ immunogenicity and the duration of their protection. The agency then transferred the technology to the Serum Institute of India and helped them scale up production. The World Health Organization prequalified the vaccine, and nearly 20 million people in Burkina Faso, Mali, and Niger have been vaccinated so far.
FDA also will seek partners with whom to pool products, resources, and knowledge to develop medical countermeasures. In a memorandum of understanding, FDA and the Defense Advanced Research Projects Agency at the US Department of Defense agreed to spur the creation of medical products. The partners are developing modular immune in vitro constructs technology that models an artificial human immune system to enable vaccine pretesting, according to Hamburg.
A full transcript of Hamburg’s remarks is available here.
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