FDA teams up for flu fight

Obligatory swine flu update, alphabet soup edition: The WHO raised the pandemic threat level to 5 (pandemic imminent or inevitable). The FDA charged seven internal "teams" with influenza-management jobs. The CDC faces a tough decision on whether to go full-bore after a vaccine, especially as virologists are starting to think this H1N1 strain may not even be as severe as the seasonal flu (just as Sanofi-Aventis's Chris Viehbacher (photo) predicted yesterday.) Officials are talking to the House Energy and Commerce Committee about the outbreak. And HHS Secretary Kathleen Sebelius (photo) is set to participate in an all-flu-star webcast later today; submit your questions now.

Meanwhile, at the FDA, some in-pipeline antivirals could find a place in the real world. Acting commissioner Joshua Sharfstein (photo) is "actively engaging all [antiviral] manufacturers so they can be ready and clinicians can have access to medicines that we think are promising." No drugs have been pegged for fast-track approval thus far, though.

The FDA is also working with diagnostics test developers to come up with faster ways to ID the virus and with personal protective equipment makers, presumably to channel masks and other PPE to the folks who need it most and to ramp up production as necessary. There's a shortage team, to monitor drug scarcity (good thing, considering the sold-out pharmacies we reported on yesterday). And a consumer-protection team aiming to protect a scared public from bogus-and-possibly-harmful products that inevitably crop up during emergencies. As we all know, scamsters love a crisis.

WHO keeps saying the flu situation is "evolving rapidly." So stay tuned for the latest.

- read Roche's latest response
- see the news roundup from MedPage Today (case counts not up to date)
- get info on the House hearing from the Washington Post
- here's a link to the HHS webcast at the agency website
- read more on an H1N1 vaccine in the Wall Street Journal