Members of Congress pointed fingers at lax FDA oversight, accusing the agency of trying to squelch staff warnings of these safety issues and ignoring signs of trouble at Chiron. Federal investigators sought evidence of unethical manufacturer behavior, as government officials and industry leaders weighed a range of messages emerging from these events:
CHIRON CRISIS For some time now, the US health care system has been plagued by shortages of many vaccines for children and unpredictable supplies of influenza vaccines. Observers describe the nation's vaccine supply system as "very fragile" and "unreliable" — characteristics that have escalated with the departure of Wyeth Pharmaceuticals and other companies from flu vaccine production. Recent shortages prompted CDC to ramp up orders for this year, particularly to meet growing demand generated by the government's own flu vaccine campaign.A key element in CDC's efforts to boost supply was enlisting San Francisco-based Chiron to provide over 40 million doses of flu vaccine this fall from its newly acquired Liverpool plant. The plan fell apart in October when British regulatory authorities suspended the facility's license due to contamination problems affecting the entire production run. While the Brits stood to lose less than 20% of their annual flu vaccine supply, an amount that other manufacturers could fill, the shutdown was devastating to the US, which was relying on Chiron for about one-half of its 100 million doses.
FDA officials rushed to England to see if there was some way to salvage any of the vaccine. Team Biologics investigators had inspected the Liverpool plant in June 2003 and found a number of manufacturing problems that appeared correctable. At that time, there was no evidence of contamination in finished doses, and Chiron said it would fix specific quality control shortcomings. But the plant had a history of manufacturing problems and had changed hands several times in the last five years. Chiron bought the facility from PowderJect Pharmaceuticals in July 2003 and spent $75 million to upgrade the facility — which may have been pouring money down a sinkhole.
In August 2004, Chiron acknowledged contamination problems with some vaccine lots but assured FDA that it was an isolated situation, easily remedied. In fact, just a few days before the shut-down, Chiron CEO Howard Pien told a Senate committee that it had addressed its contamination issues and would deliver flu vaccine as promised. FDA officials were waiting for a Chiron report when Britain's Medicines and Healthcare Products Regulatory Agency closed the plant for three months because it determined that Chiron could not ensure product quality.
RISKY BUSINESS The Chiron catastrophe spurred public interest in usually arcane production issues such as sterile vial filling and cell-based production. While US public health officials scrambled to find alternative supplies and encouraged prudent use of available doses, the situation spotlighted serious problems with the vaccine supply system. Health officials and policy makers wanted to know why FDA did not address Chiron's problems earlier. They examined why Adventis Pasteur and MedImmune are the only other licensed flu vaccine producers for the huge US market, a situation that limits possibilities for dealing with emergencies.