Preparing for the Next Pandemic

Department of Health and Human Services plans to ramp up vaccine production to stem next flu pandemic. Now that the H1N1 swine flu pandemic has officially come to an end, the federal government is planning to change the way it works with companies to counteract new disease threats. Proposed actions include reforming the Food and Drug Administration (FDA) and creating centers that will make vaccines available more quickly than was possible previously. According to a Department of Health and Human Services (HHS) report, the nation’s ability to respond to pandemics is too slow and that changes must be made. The report also contains a plan to help researchers and biotech firms bring new drugs and vaccines to the market in record time.

“At a moment when the greatest danger we face may be a virus we have never seen before…we don’t have the flexibility to adapt,” said HHS Secretary Kathleen Sebelius. The report promotes clearer guidance to industry regarding the kinds of tests need to achieve regulatory approval of new drugs and vaccines, something the pharmaceutical industry has requested. The FDA plans to establish teams to expedite this process. Additionally, HHS and the Department of Defense plan to establish the Centers for Innovation in Advanced Development and Manufacturing, according to the report.

“These centers will provide assistance to industry and government by advancing state-of-the-art, disposable, modular manufacturing process technologies,” the report says. “Finally, in public health emergencies, these centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza.”

Dr. Harold Varmus, who wrote a separate report from the Presidential Council of Advisors on Science and Technology, said “Accelerated delivery of vaccines by even a few weeks can mean saving tens of thousands of lives. Sebelius noted that the government has not invested adequately in “regulatory science” – studying the optimal means to test new products. “Because of this under-investment, we are often testing and producing cutting-edge products using science that is decades old. We are also going to reach out to product developers earlier in the process so they know what to expect,” Sebelius said.

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