After being urged by the Center for Disease Control, the Food and Drug Administration (FDA) granted an emergency use authorization (EUA) on October 26, 2009, for the H1N1 antiviral drug peramivir intravenous manufactured by Biocryst.
Over 1000 people have died from H1N1 in the United States so far this year according to the CDC.
Peramivir was "fast-tracked" by the FDA in 2007 but has yet to be approved. Japan has approved
peramivir for use after a successful phase III evaluation involving more than 1100 people. No severe adverse reactions were noted in the Japanese study that is a carbon copy of the FDA procedure. The FDA knew about these results in September 2009.
I was contacted on behalf of a person dying from H1N1 to provide information about the possibility of using peramivir to save her life. The FDA finally decided on the criteria they choose to use for EUA a week after this young woman died.
I wonder how many more lives might have been saved by a more timely action by the CDC and the FDA.
Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:
the patient is not responding to either oral or inhaled antiviral therapy, or when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible; for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
The FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.
Peramivir is the only intravenously administered influenza treatment currently authorized for use
under EUA for 2009 H1N1 infections.
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unproved or uncleared medical products or unproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.
http://www.cdc.gov/h1n1flu/eua/
1-800-CDC-INFO ( 1-800-232-4636 ).
I hope this is the straw that breaks the FDA back and forces a complete overhaul of this money manipulated antique.
Comments
Well said! Congress needs to investigate why the FDA approved peramivir under an Emergency IND in mid-June, and then NEVER told emergency room and ICU doctors about it. The CDC did NOT revise their antiviral guidelines to tell doctors, and all concerned would NOT let BioCryst get out the word. As a result, less than 20 courses of peramivir got to doctors from mid-June until now. Of the 10 cases that used peramivir that CBS News found, 8 did not die. The other two probably got it too late due to all the red tape. This was a shocking failure of the emergency response system Congress put in place after 9/11, and needs to be thoroughly investigated before an even bigger emergency occurs. Write you Congressman!
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