House Subcommittee Requests Additional Documents Related to Flu Vaccine Shortage
In a hearing on the national flu vaccine shortage, the House Energy and Commerce Subcommittee on Health on Thursday requested that FDA, HHS and flu vaccine manufacturer Chiron by Dec. 1 produce documents detailing the agencies' inspection processes for international manufacturing plants, along with internal documents, communications between officials and other records, USA Today reports (Appleby, USA Today, 11/19). The U.S. flu vaccine supply shortage became apparent on Oct. 6 when California-based Chiron announced that the British Medicines and Healthcare Products Regulatory Agency suspended for three months the company's manufacturing license at a Liverpool, England, plant that produces about half of the United States' flu vaccine supply. As a result, Chiron will not ship any flu vaccine doses to the United States this season.
U.S. officials expected to have about 100 million flu vaccine doses this year. France-based Aventis Pasteur has provided the United States with 58 million flu vaccine doses, and Maryland-based MedImmune provided about three million doses of the nasal-spray flu vaccine FluMist. Thursday's hearing follows a Senate Special Committee on Aging hearing on Tuesday and a House Committee on Government Reform hearing on Wednesday on the issue (California Healthline, 11/18).
Samantha Jordan, a spokesperson for Energy and Commerce Committee Chair Joe Barton (R-Texas), said the committee wants information that can answer the question, "What did they know and when did they know it?" Chiron attorney Robert Bennett said the company would cooperate with the investigation (Gellene, Los Angeles Times, 11/19).
FDA Acting Commissioner Lester Crawford during Thursday's hearing said FDA inspects vaccine plants such as Chiron's every two years. Crawford also said that FDA since 2000 has hired additional new inspectors, but he did not elaborate. Crawford also clarified a comment he made Wednesday, when he stated that deficiencies cited in a 2003 FDA inspection of Chiron's Liverpool plant were not related to the contamination problems that led MHRA to suspend the company's license this year.
Crawford said that the problems cited in 2003 were corrected and the company that year produced a sterile vaccine supply. However, he said, "The problems resurfaced." Crawford said that manufacturing problems detailed in FDA's 2003 inspection report stemmed from former owners of the plant, which Chiron acquired in 2002 (USA Today, 11/19).
Committee ranking member John Dingell (D-Mich.) called the health agencies' foreign inspection processes a "faith-based initiative" and "no more than an international honor system." Dingell said, "It appears the watchdogs have been resting tranquilly by their serious responsibilities."
However, Barton said, "There are some people who seem to view the current crisis as an opportunity to score partisan points" (CongressDaily, 11/18).
Correcting vaccine manufacturing problems in time for the 2005 flu season will require "strenuous effort" and "significant investment" from Chiron and FDA, an unnamed biotechnology manufacturing consultant told the Contra Costa Times. The consultant called Chiron's circumstances "a very bad situation" that exceeds nearly all other drug manufacturers' operational problems. The consultant also said repairing the issue could require constructing a new manufacturing plant, which could take years (Silber, Contra Costa Times, 11/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.