With swine flu leaping international boundaries at an accelerated pace, FDA authorized broader use of the antivirals Tamiflu (Roche) and Relenza (GlaxoSmithKline)--and allowed a broader cross-section of professionals and volunteers to distribute the meds. Now, some public health officials and volunteers can hand out the prescription drugs, rather than just doctors and P.A.'s. And the drugs can be used off-label; for instance, Tamiflu can be given to kids under 1 year, even though that's not an FDA-approved use.
Under what's called an "Emergency Use Authorization," the agency also is allowed to authorize the use of medical products that haven't yet been approved. No word yet on whether any experimental remedies might get the FDA go-ahead, but it's early days yet. Depending upon the flu virus's spread--and on its yet-to-be-ascertained virulence/fatality rate--the agency may have to resort to unproven drugs. But then again, maybe it won't.
Meanwhile, Glaxo and Roche have stepped up their production of Relenza and Tamiflu, knowing that the two antivirals are the only remedies until a vaccine can be developed--which would take at least four months--and then mass-produced. Positioning themselves for vaccine R&D are a number of drugmakers, including perennial vaccine developers Sanofi-Aventis and Baxter.
And illustrating just why Glaxo and Roche have to step up their manufacturing, Homeland Security Secretary Janet Napolitano said 25 percent of the antiviral "treatment courses" stockpiled were being released for use. Overall, the U.S. government has 50 million courses of treatment on hand, so that means 12.5 million are on their way out the doors. Here's hoping they're never needed.
- read the FDA statement
- see the story from Bloomberg