Letter to Secretary of Health and Human Services Tommy Thompson

October 21, 2004

Dear Secretary Thompson,

On October 5, 2004, Chiron Corporation announced it would not be able to supply flu vaccine to the American market for the 2004-2005 influenza season. As a result, companies, clinics, pharmacies, and individual providers have canceled or seriously curtailed their influenza vaccination efforts. It is apparent that the country will simply not have sufficient supplies of vaccine for even the recommended high-risk populations this year.

It is even more alarming that recent news reports indicate that officials at the Food and Drug Administration (FDA) were aware of potential manufacturing problems at Chiron's Liverpool, England facility as early as June of 2003, when there was still time to prevent a crisis. However, it appears that the agency took no further action to investigate the matter or inform other agencies involved with vaccination efforts at the Department of Health and Human Services until after the British regulatory authority, the Medicines and Healthcare Products Regulatory Agency, suspended Chiron's license last week.

As you well know, our vaccine supply system is extremely fragile. While all vaccines are difficult to manufacture and require adherence with the highest standards to ensure quality and safety, the influenza vaccine is particularly challenging to produce. It is even more disturbing that when many disease experts are predicting the next flu pandemic is imminent, this country seems to be woefully unprepared to deal with what is a relatively predictable annual occurrence.

The present crisis that our nation faces is unacceptable, particularly if precautionary measures could have been taken to avoid a shortage. We understand that the Acting Commissioner of the FDA has stated that the agency was not aware of the extent of the problem until just recently. However, FDA inspectors acknowledge that during a 2003 inspection of the Liverpool facility, certain batches of the vaccine were contaminated. Yet, FDA appears to have relied solely on the word of the manufacturer that these problems had actually been resolved.

Indeed, if the FDA knew back in 2003 of contamination concerns at the plant and did not take action to make sure these
problems had been remedied, then there has been a serious failure at FDA in performing one of its most basic functions in terms of its mission to ensure the safety and efficacy of products for American patients and consumers.

We believe these are very significant issues that must be investigated and resolved without delay, and, therefore, we call upon you to immediately initiate an investigation by the HHS Office of the Inspector General (OIG) to determine exactly what information the FDA had about manufacturing problems at the Chiron vaccine plant in Liverpool, when it was made aware of these issues and what steps, if any, were taken. We would also ask that the OIG explore possible barriers to communication and information sharing between U.S. regulatory authorities and their counterparts in other countries.

Clearly, it is in the interest of the federal government to preserve and protect the health of our citizens. We appreciate your consideration of this request and look forward to working with you to ensure that we are doing all we can to achieve this important objective.

Senator Jack Reed
Senator Frank Lautenberg
Senator Tim Johnson
Senator Tom Daschle
Senator Jon S. Corzine
Senator Hillary Rodham Clinton
Senator Charles E. Schumer
Senator Mark Dayton
Senator Barbara Boxer