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Paulsen Urges FDA's Gottlieb to Act on Groundbreaking Flu Drug

Washington, D.C.– Congressman Erik Paulsen (MN-03) urged FDA Commissioner Scott Gottlieb last week to direct the FDA to research the safety and effectiveness of Xofluza, an innovative influenza treatment that has the potential to kill the flu virus in as little as a day. The drug, which has the generic name of baloxavir marboxil, has received fast-track approval in Japan and could be available to consumers there as early as May.

“This promising product could provide an answer to deadly flu viruses which yearly spread throughout Minnesota, devastating elderly and newborn Minnesotans in particular,”Paulsen wrote Gottlieb. “According to the Minnesota Department of Health, over 5,000 Minnesotans have been hospitalized due to influenza during this especially severe season. The Center for Disease Control has also reported that influenza epidemics can sometimes claim over 100 Minnesotan lives a week during peak flu season times. The research breakthroughs of Xofluza offer promising results, including more quickly reducing contagious effects of the virus and completely alleviating symptoms sooner than current alternatives.”

The new drug has the potential to be much more effective than Tamiflu or other existing drugs used to treat influenza. Late-stage trials are in progress but the drug has yet to be approved by the FDA for sale in the U.S.

“As the Administration seeks to improve efficiency of medical treatments for this public health challenge, the innovative methods of Xofluza warrant detailed attention,”Paulsen continued.

“I hope to learn how the Administration recommends pursuing timely solutions to this pressing public health need of the state of Minnesota,”Paulsen concluded.

 

The full text of the letter is below:

 

Scott Gottlieb, MD

Commissioner of Food and Drugs

U.S. Food and Drug Administration

Department of Health and Human Services

10903 New Hampshire Avenue         

Silver Spring, MD 20993

 

Dear Commissioner Gottlieb:

I write to you to express my strong interest in the recently announced influenza treatment baloxavir marboxil, or Xofluza. Pioneered by Shionogi & Company, I encourage the Administration to further research and study the potential benefits of this innovative medicine to address influenza epidemics.

This promising product could provide an answer to deadly flu viruses which yearly spread throughout Minnesota, devastating elderly and newborn Minnesotans in particular. According to the Minnesota Department of Health, over 5,000 Minnesotans have been hospitalized due to influenza during this especially severe season. The Center for Disease Control has also reported that influenza epidemics can sometimes claim over 100 Minnesotan lives a week during peak flu season times. The research breakthroughs of Xofluza offer promising results, including more quickly reducing contagious effects of the virus and completely alleviating symptoms sooner than current alternatives.

As the Administration seeks to improve efficiency of medical treatments for this public health challenge, the innovative methods of Xofluza warrant detailed attention. The drug prevents the reproduction of influenza virus through previously unexplored methods. The medicine’s critical importance to public health earned the drug a “priority review” by the Ministry of Health, Labour, and Welfare of Japan in 2015. By this process, potential treatments are given priority regulatory evaluation to ensure they are supplied to clinical settings at the earliest possible opportunity.

I look forward to enabling our nation to better combat influenza epidemics through rapid implementation of scientifically-proven innovations. Addressing outbreaks of cold and flu viruses, which particularly threatens the most vulnerable Minnesotans, requires that the latest research advancements are made available to the public as soon as possible.

I hope to learn how the Administration recommends pursuing timely solutions to this pressing public health need of the state of Minnesota.

  

Sincerely,

 

 

 

Erik Paulsen

Member of Congress

 

 

Congressman Paulsen, a champion of small business and advocate of free enterprise, entrepreneurship, and innovation, serves on the House Ways and Means Committee, chairs the bicameral Joint Economic Committee, and is co-chair of the Congressional Medical Technology Caucus.

 

For more information on Congressman Paulsen’s work in Congress visit paulsen.house.gov