THE US government proposed significant changes yesterday to the way it works with companies to fight new disease threats such as flu, including reform at the Food and Drug Administration (FDA) and setting up centres to make vaccines quickly.
The report from the health and human services department stated the US ability to respond to new outbreaks is too slow and it lays out a plan for helping researchers and biotechnology firms develop drugs and vaccines.
“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,” health and human services secretary Kathleen Sebelius said at a news briefing.
The report suggests providing clearer guidance to industry on what kinds of tests are needed for regulatory approval of new drugs and vaccines – something industry has asked for – and says new teams should be set up at the FDA to facilitate this.
Experts in industry and the government have long agreed that the US system for producing drugs and vaccines to fight pandemics, especially influenza, is slow and unwieldy. It takes months to make a vaccine against influenza using current processes. While firms are working to modernise their abilities, any big changes are years away. By the time companies were able to make a vaccine against the H1N1 swine flu pandemic virus last year, it was already spreading around the world.
“Accelerated delivery of vaccines by even a few weeks can mean saving tens of thousands of lives,” Dr Harold Varmus, who helped write a separate report from the Presidential Council of Advisors on Science and Technology, told the news conference.
The report also calls for better surveillance to give a much quicker alert when new diseases emerge. Studies show H1N1 had been circulating for weeks or months before it was detected.
Companies have complained that federal rules are confusing and do not help much. The report takes many of the concerns into account.