On October 5, 2004, British regulators shut down a Liverpool manufacturing facility that had planned to provide almost half of the supply of flu shots in the United States this year. The result is a shortage that has left at least 30 million seniors, infants, and others at high risk without access to the flu vaccine. Rep. Waxman has been seeking the release of documents relating to the crisis from FDA.
At a Committee hearing on flu preparedness, Rep. Waxman identifies significant problems in the Administration's flu preparedness plan, including FEMA's protection role, liability shields for manufacturers, and inadequate funding.
There has been a sharp decline in FDA enforcement actions against misleading drug advertisements and violations of manufacturing standards by biologic drug companies since Dr. Lestor Crawford was appointed as Acting Commissioner in early 2002.
Rep. Waxman and Chairman Davis write Secretary Thompson to object to a plan to use CDC's child immunization funds to purchase flu vaccine from abroad.
Acting FDA Commissioner Dr. Lester Crawford's testimony maintained that FDA made no mistakes that contributed to the flu vaccine crisis, but a review of the record reveals conflicting evidence from FDA documents, statements made by senior FDA staff, and basic facts about FDA's regulatory system.
New FDA documents raise serious questions about the agency’s oversight of the Chiron facility that was scheduled to deliver half of the nation’s flu shot supply this year.
Rep. Waxman asks FDA Commissioner Crawford to respond to a confidential communication received from inside his agency indicating that the Commissioner’s office is withholding documents that address whether the flu vaccine crisis could have been prevented.
Rep. Waxman criticizes FDA for failing to release key documents about whether the flu vaccine crisis could have been prevented and asks Chairman Davis to issue an immediate subpoena.
Rep. Waxman releases four new fact sheets that explain (1) how the Administration ignored years of expert recommendations on vaccine supply; (2) how the Administration failed to invest in efforts to strengthen the vaccine supply, (3) how FDA failed to respond to warning signs at the contaminated facility; and (4) how liability concerns are irrelevant to the current crisis.
Rep. Waxman and Chairman Davis ask the Federal Trade Commission to examine reports that some distributors are charging exorbitant prices for the flu vaccine.
Rep. Waxman and Chairman Davis ask for the release of documents detailing what FDA knew about problems at the manufacturing facility that was shut down last week by British regulators, triggering the flu vaccine shortage.
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