Washington, DC -- Today Rep. Ed Markey (D-MA), a senior member of the House Energy and Commerce Committee, urged the Food and Drug Administration (FDA) to explain the flu vaccine manufacturing problems at a major domestic producer of flu vaccine, Sanofi-Pasteur.  Rep. Markey sent a letter to FDA Commissioner Andrew von Eschenbach, M.D. pushing him to ensure that the nation’s supply of flu vaccine going into the fall flu season is adequate and will not be affected by a possible shut down of the Sanofi-Pasteur plant.  Rep. Markey is also recommending that the FDA, if they haven’t done it already, make sure that the other flu vaccine-producing companies can ramp up production if Sanofi-Pasteur cannot make safe vaccines this season.  Sanofi-Pasteur has said it plans to make about 50 million doses of the vaccine this season, approximately one half of the entire U.S. supply.

Rep. Markey said, “There is no more important issue for the Food and Drug Administration than assuring the public supply of untainted flu vaccine in the fall.  The latest warning letter to one of our primary suppliers is very troubling and raises the possibility that supplies could be drastically curtailed.  The FDA relied on private promises to fix these problems for over a year, only to learn that the problems were not fixed and have gotten worse. While private warnings to companies may stave off short term public relations problems, the FDA’s mission is to protect the public health, not public relations.  Let us hope that by allowing those warnings to go unheeded for over a year, the FDA has not created a serious health problem, particularly for the elderly and young children who are most susceptible to the flu.”

“The Bush Administration has neglected its responsibility to the public health repeatedly and this is just another example of what lax federal oversight can result in – a potential shortfall in flu vaccine unless serious steps are taken by the FDA to remedy the problems at the Sanofi-Pasteur plant or significantly ramp up production at other facilities,” Rep. Markey concluded.

Markey’s letter to the FDA Commissioner is below:

July 6, 2006
Andrew C. von Eschenbach, M.D.
Acting Commissioner
US Food and Drug Administration
U.S. Department of Health and Human Services
Parklawn Building
5600 Fishers Lane, Room 15-47
Rockville, MD 20857

Dear Dr. von Eschenbach:

I am writing in regard to the recent reports that the Food and Drug Administration (FDA) has identified and issued a warning letter regarding serious problems with influenza vaccine at the Sanofi-Pasteur manufacturing plant in Swiftwater, Pennsylvania. I am very concerned about the impact of these manufacturing problems on the availability of vaccine for this fall’s flu season.

In 2004, serious problems with the annual influenza vaccine at Chiron Corp. manufacturing plant in Liverpool England resulted in the closure of the plant. As a result, the United States experienced a nationwide flu vaccine shortage. Luckily, the vaccine shortage was mitigated by the fact that Sanofi- Pasteur increased production to compensate for the losses at Chiron. When similar problems arose again at Chiron last year, Sanofi-Pasteur once again increased production to compensate for the loss of vaccine from Chiron.

In light of the reports that Sanofi-Pasteur now has its own manufacturing problems and may not be able to provide sufficient vaccine for this year’s flu season, I am concerned about impact on the availability of vaccine for this fall’s flu season. In light of these concerns, I respectfully request that the FDA provide response to the following questions:

    1. According to the FDA’s warning letter, a March 2005 inspection identified several problems at Sanofi-Pasteur that were not corrected prior to the 2006 inspection. Please provide a list of all of the problems identified by the FDA in prior inspections that were not resolved by the April 2006 inspection and indicate when the problems were first identified.
    2. In light of the prior failure of Sanofi-Pasteur to correct problems identified by the FDA, should the public be concerned that Sanofi-Pasteur may not be able to correct the problems identified in the warning letter? Please explain.
    3. Why did the FDA decide not to issue a warning letter in March 2005? Does the FDA regret that decision?
    4. When does the FDA anticipate that Sanofi-Pasteur will be able to resolve the identified problems? What is the FDA doing to ensure that the problems are resolved?
    5. If Sanofi-Pasteur is not able to resolve the current issues and has to close like Chiron did in 2004, what impact will that have on the availability of vaccine for this fall’s flu season? In the event that Sanofi-Pasteur cannot provide the anticipated amount of vaccine this year, what plan does the FDA have to ensure that our country has an adequate supply of vaccine for this fall’s flu season?
    6. Is the FDA confident that the other influenza vaccine manufacturing plants are problem free and will be able to provide adequate influenza vaccine this year? Please list each influenza manufacturing facility that is a source of vaccine and indicate the date of the most recent FDA inspection of each facility.  For each facility, please list all manufacturing problems, if any, uncovered by these inspections, or by voluntary reporting, that could affect adequate production of the vaccine for the upcoming flu season.
    7. In light of the fact that Sanofi-Pasteur has for the past two years increased their supply of vaccine in order to compensate for the failures of other manufacturing plants, if another plant has problems with their vaccine production, who will compensate for those losses?

Thank you for your attention to this important issue. I respectfully request a response by July 24, 2006. I look forward to your prompt reply.

                        Sincerely,

                        Edward J. Markey

For further information, visit http://markey.house.gov.