US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government’s system to produce medical countermeasures, (e.g., medications, vaccines, equipment, and supplies) needed for health emergencies. The report, The Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs, reviews the system and makes recommendations, including suggestions for improving vaccine manufacturing and investment.
“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,” Sebelius said in an HHS press release. “By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public-health threats.”
Sebelius requested the review when HHS encountered challenges with the 2009 H1N1 pandemic flu vaccine, which highlighted the need for a modernized countermeasure-production process. The review covered the steps involved in the research, development, and US Food and Drug Administration approval of medications, vaccines, medical equipment, and supplies for a health emergency. The review identified a need to upgrade science and regulatory capacity at FDA. HHS said it “will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market,” according to the HHS release.
The review also found that the US must quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes that can be used to produce only one type of countermeasure. HHS said it expects to release in the coming weeks a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the US rather than relying on foreign manufacturing, according to the HHS release. The review also identified a need to upgrade flu-vaccine manufacturing by modernizing methods for testing a vaccine’s potency, efficacy, and safety and by establishing ways to produce the early seed virus for vaccines faster. HHS said it will invest in these areas as a result of the review.
The review found that small, emerging biotechnology companies often conduct the most promising research and development on countermeasures, but they have little experience in large-scale manufacturing. The proposed Centers of Innovation for Advanced Development and Manufacturing will provide resources for emerging companies to help the US realize its goal of increasing the number of new countermeasures available in an emergency, according to HHS.
To better encourage innovation, HHS said it will create new teams at the National Institutes of Health (NIH) to identify promising research and facilitate its translation into vaccines, drugs, and other medical treatments. The review noted that private companies have difficulty attracting investors in countermeasures because there is little or no market for these products outside of that currently needed for government stockpiles. HHS said it “will explore ways to help small companies attract investors to develop promising countermeasures that have multiuse potential,” according to the HHS release.
All federal agencies working with medical countermeasures participated in the review. These agencies included the US Department of Homeland Security, the US Department of Defense, and HHS's divisions of the Assistant Secretary for Preparedness and Response (ASPR), ASPR’s Biomedical Advanced Research and Development Authority, NIH, the Centers for Disease Control and Prevention, and FDA. The review also incorporated input from state and local health departments, two federal advisory committees of outside experts, industry groups, venture-capital experts, and the Institute of Medicine.