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MedKit Development For Flu Outbreak Is “Part Of The Discussion”– Sharfstein

This article was originally published in The Tan Sheet

Executive Summary

The spread of the 2009-H1N1 flu virus in the U.S. is not prompting FDA to accelerate work on a proposed program for home stockpiling of antiviral drugs, acting Commissioner Josh Sharfstein says

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MedKit on HHS backburner

A program that potentially could allow home stockpiling of antiviral drugs is on hold, according to the head of the Department of Health and Human Services unit overseeing it. "The MedKit concept requires further study and discussion within the medical and public health communities," said Robin Robinson, director of the Biomedical Advanced Research and Development Authority, in a Sept. 10 e-mail. "Right now, overall, the concept is on hold with resources reassigned to even more pressing needs," including ensuring sufficient supplies of antiviral flu drugs, he added. Despite BARDA's shift in priorities, the antiviral drug sponsors involved with the program say they continue to generate science in support of MedKit development. David Reddy, the pandemic taskforce leader for Roche, said during a Sept. 11 media call that the company is undertaking mixing and dosing studies on its Tamiflu (oseltamivir) to establish a foundation of data. However, he added, Roche is "not at the stage of fighting for approval for the MedKits." GlaxoSmithKline, maker of Relenza (zanamivir), is working on a Relenza MedKit, but ensuring adequate Relenza inventory and working on a vaccine for the H1N1 flu virus are of greater import, a spokesman said. He added that it is unclear whether GSK will submit a new drug application for the Relenza MedKit to FDA in 2010, as an earlier timeline had projected (1"The Tan Sheet" May 4, 2009). FDA acknowledged in spring 2009 the MedKit concept was being discussed, but an agency spokeswoman declined to comment on where FDA currently stands on the program

FDA Gives Firms Hawking H1N1 Remedies Tighter Deadline To Comply

FDA's threats of near-immediate action against firms selling products with claims of treating the 2009-H1N1 flu virus are the sign of a fleet-footed and serious agency, says a food and drug attorney

FDA Learned Consumer Protection Lesson From 2004 Flu Scare

The roster of teams FDA assembled to respond to the 2009-N1H1 flu outbreak includes a consumer protection group to identify potentially dangerous products marketed as cures for the virus

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