DeLauro Call for Inspector General Investigation of Flu Vaccine Shortage

DeLauro Calls for Inspector General Investigation on Flu Vaccine Shortage

WASHINGTON - Congresswoman Rosa L. DeLauro (Conn.-3) today sent a letter to Department of Health and Human Services Secretary Tommy Thompson requesting that he launch an Inspector General (IG) investigation into the shortage of flu vaccines in the U.S. DeLauro's request comes days after the FDA announced that none of the vaccines produced by American company Chiron Corporation in its Liverpool, UK facility were suitable for use.

According to the Government Accountability Office (GAO), each year an estimated 36,000 deaths and 200,000 hospitalizations are attributed to the flu. Director Julie Gerberding of the Centers for Disease Control and Prevention (CDC) has said that we can expect that number to increase to some extent due to the shortfall of vaccines.

"The crisis in delivery of flu vaccines to the U.S. this year is a life and death health care issue," said DeLauro. "Following last year's vaccine shortage, FDA should have been more resolute this year with oversight of this critical health need. Federal public health officials - charged with oversight of this industry - were asleep at the switch."

DeLauro pointed to conflicting media reports since the shortage was announced. British regulators claim FDA knew the Chiron plant in Liverpool would not be able to provide the 46 to 48 million does expected. FDA, however, claims it was not informed of the problem's seriousness. Chiron appeared before Congress the week before the close of its plant to testify that all was well and the vaccines would be coming.

"Clearly there was a serious breakdown in the system, and we need to know exactly what happened and what can be done to prevent it from happening again," said DeLauro. "An Inspector General report will provide these answers to the American people."

DeLauro is a member of the House Appropriations Committee Subcommittee on Agriculture, which has jurisdiction over the FDA.

The full text of the letter follows.

October 15, 2004

The Honorable Tommy Thompson
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201

Dear Mr. Secretary:

I am writing to you today about the crisis in delivery of flu vaccine. As I travel through my district, my constituents are asking me how we arrived in this situation where the United States is actually rationing access to a critical vaccine? They understand how serious this disease can be, especially since approximately 36,000 people die every year in the United States, and Director Gerberding of the Centers for Disease Control and Prevention (CDC) has said that we can expect that number to increase to some extent due to the shortfall of vaccines.

And I understand that experts believe it is only a matter of time until we have influenza pandemic - something like happened worldwide in 1917. A terrible strain of flu would require much better planning and vaccines that would need to be prepared in a short time. We seem unprepared for that also.

Since the news surfaced on October 5th, we have seen conflicting reports about how this happened. The British say the Food and Drug Administration (FDA) knew what would happen to the Chiron plant in Liverpool, but the FDA says it was not informed of the problem's seriousness. Chiron appeared before the Congress the week before the close of its plant to tell us that all was well and the vaccines would be coming. Clearly there was a serious breakdown in the system, and we need to know exactly what happened and what can be done to prevent it from happening again.

I urge you to begin an investigation by the Department's Inspector General so the American people have an explanation of what went wrong, what actions are being taken to mitigate the shortage of the vaccine, how you plan to ensure that this will never happen again, and your recommendations for the long-range solution of vaccine development, production and delivery for flu and other diseases requiring biologics.

The Administration has had almost four years to develop solutions to a pandemic flu possibility, and to manage our yearly flu outbreaks, but it appears that a plan and a solution are not close. FDA has made many statements about its suspicions about products manufactured in or re-imported from Western Europe or Canada, yet in this instance, in which the U.S. is dependent on an outsourced plant bought by Chiron, the reverse seems to be true. According to media reports, the British regulatory system took action, but FDA did not inspect Chiron enough to predict the shutdown by the British regulatory authorities. An absolutely critical product was produced off-shore with inadequate oversight by the U.S. authorities, leaving American seniors and children vulnerable to a flu outbreak, and the rest of the population to suffer work loss and illness.

I will look for your prompt response.

Sincerely,


Rosa L. DeLauro
Member of Congress