Representative Henry Waxman House Committee on Government Reform From:
Senior Policy Analyst
Influenza Shortage Distribution Recommendations
This memo outlines ways to address the recurring shortages of the influenza vaccine that occurred in the United States between 2000 and 2004. There were two important contributing factors to these vaccine shortages. First, there has been a significant reduction over the past few decades in the number of companies that choose to manufacture the flu vaccine. Second, the government has taken a laissez-faire approach to managing the distribution of the vaccine, even in times of shortage. In order to fully accomplish our overarching goal – to maximize stability and availability of the flu vaccine, particularly to Americans who are at highest risk of complications from the virus – I believe proper distribution of the flu vaccine must be more accessible to more channel of distribution to maintain an adequate supply of the flu vaccine. In order to do this, legislation must ensure that adequate supply of the vaccine is available during various flu seasons. Legislation must also encourage effective collaboration with private companies as they are the primary distributors of flu vaccine as well. In this memo, I recommend imposing a window period for the priority distribution of the flu vaccine to high-risk Americans in the event of a shortage. I also recommend exploring further the idea of providing government incentives to create a lucrative environment so that producing vaccine is a more enticing market for private companies to enter. Primary Issues in Addressing the Flu Vaccine Distribution and Manufacturing As you consider policy solutions to bring greater stability the U.S. influenza vaccine supply, I propose that you take into consideration three underlying issues: Diminishing numbers of vaccine manufacturers
In recent years, the number of companies that manufacture the flu vaccine has been reduced significantly, from 25 companies three decades ago to only five as of 2003. With a smaller universe of manufacturers, ensuring that an adequate supply of the vaccine is available for the 90 million Americans at the greatest risk of complications from the virus has become more challenging. Those manufacturers that have ceased to produce the vaccine have cited low profits, unpredictable demand and overly burdensome regulations as reasons for their decisions to stop manufacturing the vaccine. For example, pharmaceutical giant Merck & Co. abandoned the flu vaccine business almost twenty years ago. Wyeth pulled out last year after throwing away about one-third of the flu vaccine it made for the 2002-2003 season because it did not sell. That leaves just three established companies in the business--the French firm Aventis Pasteur SA, Chiron Corporation, and Medimmune, Inc. With such a limited set of manufacturers, problems at just one lab could imperil the ability of the entire U.S. health care system to deliver vaccines to all who need them, as was the case when the U.S. learned that vaccines produced by Chiron in Liverpool were contaminated. While the oversight by the Federal Drug Administration was also to blame for this debacle, we cannot ignore that our overreliance on just a few manufacturers is at the root of the instability of our vaccine supply. Poor Regulations
Poor regulation has led to a discrepancy in the production, sale, and distribution of the flu vaccine, which are currently operated by private enterprises. Vaccine distribution, when left to existing private enterprises Chiron and Aventis, resulted in uneven distribution of medication in 2004. If the Department of Health is unaware of how flu supplies are shipped and to who they are shipped to, there is no way the Department of Health and Human Services can intervene in assisting companies to distributing the vaccinations. In addition, poor regulation policies...
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