Statement of Congressman John D. Dingell, Ranking Member
Committee on Energy and Commerce

SUBCOMMITTEE ON HEALTH
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
JOINT HEARING ON "FLU VACCINE:
PROTECTING HIGH- RISK INDIVIDUALS 
AND STRENGTHENING THE MARKET"

November 18, 2004

Mr. Chairman, thank you for scheduling this hearing on responding to the severe shortage of flu vaccine this year. All of us are hearing from constituents who are justifiably alarmed by this situation. They are alarmed for themselves and they are alarmed for their loved ones. We need to learn what got us to this point, and most importantly, we need to determine how to reduce the risk of repeating this mess.

As a preliminary matter, how and why did this immediate problem occur? What happened at Chiron? Did the Food and Drug Administration (FDA) fully and wisely exercise its authority? Is the foreign inspection system broken?

It appears at first glance that answers to these questions will give the American people little comfort. Chiron purchased a chronically troubled facility, and was insufficiently aggressive in addressing shortcomings. FDA allowed the problems to fester, and was laggard in reacting to bad news. And, yes, as our hearings showed in 2000, the FDA’s foreign inspection program, which is often little more than an international honor system, is badly underfunded and is in disarray. Congress needs to get to the bottom of this, and the Committee on Government Reform has done important and useful work on what happened here.

But Congress also must not wait to act on the underlying vulnerability of the vaccine supply that this sorry episode has revealed. I recently announced my interest in developing bipartisan legislation aimed at ensuring an adequate and reliable supply of safe and effective flu vaccines. I have outlined some elements that should help to achieve that goal, including (1) guaranteeing adequate vaccine supplies, (2) providing compensation to those injured, (3) enhancing vaccine research efforts, (4) improving FDA inspection of flu vaccine manufacturing, (5) improving the FDA review process for new flu vaccines, (6) authorizing emergency vaccine allocation procedures, and (7) providing for continued monitoring and accountability.

Mr. Chairman, I hope that in the best bipartisan tradition of this Committee we will work together on this issue, and soon. It is not an exaggeration to say that this is among the most important public health matters we face, now and in the future. If we do a good job addressing the matter of annual vaccines for influenza, we may very well also be improving our chances of minimizing the damage that will be caused by the next influenza pandemic.

A lot of work has already been done to identify policy options. The Institute of Medicine, the Government Accountability Office, advisory committees, and others have sifted through mountains of data and provided thoughtful analysis. It is now time for us to assess the policy options and to act.

Today’s hearing is a good start, with an excellent array of witnesses. I am particularly pleased to welcome, from the state of Michigan, Janet Olszewski, the Director of the Michigan Department of Community Health. She will provide an important perspective from the state level on programs and policies in use to manage this year’s severe shortage of flu vaccine. She joins our other distinguished witnesses, and I thank you all for appearing before us today.

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(Contact: Jodi Seth, 202-225-3641)