Flu Vaccine Crisis

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.

Latest News

Problems Remain With Administration Flu Plan

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.

FDA Enforcement Efforts Decline

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.

HHS Asked to Reconsider Flu Vaccine Measure

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.

FDA Testimony to Congress on the Flu Vaccine Shortage

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.

FDA Failed to Oversee Vaccine Plant

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.

Source: FDA Withholding Flu Vaccine Documents

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.

Administration Withholding Flu Vaccine Documents

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.

The Facts on the Flu Vaccine Crisis

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.

FTC Asked to Begin Inquiry into Flu Vaccine Price Gouging

Rep. Waxman and Chairman Davis ask the Federal Trade Commission to examine reports that some distributors are charging exorbitant prices for the flu vaccine.

Questions for FDA on Suspension of Flu Shot Manufacturer

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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