DeLauro Call on HHS To Prevent Vaccine Shortages

DeLauro Calls on HHS To Prevent Vaccine Shortages

NEW HAVEN - The Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) announced with finality yesterday, that after sending inspectors to England to meet with Chiron Corporation about its supply of flu vaccine, none of the vaccine manufactured in Liverpool, UK, was suitable for use. The United States supply of flu vaccine was scheduled to come from two sources, Chiron Corp., a California company, and Aventis Pasteur, a French owned company, manufacturing in Pennsylvania. The 46 to 48 million doses expected from Chiron will not be available.

"The flu-vaccine shortage is the latest in a series of major administrative and management problems emerging in our Nation's public health system. Last week, when Centers for Disease Control and Prevention (CDC) Director, Julie Gerberding, was asked to estimate the prospective result from the shortage, she indicated there could be additional deaths beyond the approximately 36,000 patients in the United States who die each year from flu.

"Most troubling to me is the fact that there is not even agreement between the FDA regulators and the British regulators from their Medicines Healthcare Regulatory Agency (MHRA) about who knew what when. MHRA is standing by its statement that FDA knew in mid-September of continuing problems at the Chiron plant in Liverpool. Press reports raised questions about Chiron's ability to manufacture effectively in Liverpool as early as August.

"We have watched FDA's oversight of both its drug and food responsibilities diminish even as the challenges increase. I am now communicating my concern and requesting a prompt investigation and report from Health and Human Services Secretary Tommy Thompson to whom the Centers for Disease Control and Prevention, the National Institutes for Health and the Food and Drug Administration all report. We need to know what is being done to prevent such a breakdown in the future, and what HHS is doing to advance research on vaccine development and production."