25 October 2004

Ill. Gov seeks federal OK to buy flu vaccine from Europe

Days before a presidential election where a flu vaccine shortage is an issue, Gov. Blagojevich today will seek federal permission to import 30,000 doses from Europe for Illinois nursing home residents.

 The FDA is likely to reject the Blagojevich request in the latest chapter of an ongoing struggle between Illinois and the Bush administration that is part of the national debate over importing prescription drugs from other countries.

 Ten days ago, the U.S. Food and Drug Administration said the government was contacting every vaccine maker in the world for additional supplies, but did not not want to create "false hope'' while exploring "every option.''

 On Sunday, a spokesman for the FDA who did not want his name used said the agency had not received the letter from Blagojevich, echoing the earlier statement.

 "The Department of Health and Human Services and the FDA have been and are committed to working expeditiously to identify and make available to U.S. citizens in those high-risk categories established by the Centers for Disease Control and Prevention all potential worldwide sources of safe influenza vaccine,'' the spokesman said.

 Illinois defied the FDA earlier this month when it launched a service to help residents buy cheaper prescription drugs from Canada, Great Britain and Ireland. Drug purchases from other countries are illegal, but the FDA has not tried to shut down the plan, called the "I-Save-Rx'' program.

 Seeks 30,000 doses

 Blagojevich is sending a letter today to Lester Crawford, the acting FDA commissioner, asking for approval to purchase at least 30,000 doses of flu vaccine made by Aventis Pasteur, a French pharmaceutical company in its Lyons plant.

 Aventis Pasteur is already providing more that 54 million doses of flu vaccine and FluMist nasal spray to the United States.

 "The only barrier to distributing the vaccine to Illinois residents is clearance by the Food and Drug Administration,'' Blagojevich said in his letter to Crawford.

 The state learned of the potential to buy the flu vaccines from the governor's staffers who work on and helped develop the I-Save-Rx program, Scott McKibbin and Ram Kamath. The state employees were in Great Britain to deal with suppliers and pharmacies doing business with I-Save-Rx.

 Well aware of the flu vaccine shortage, they scouted around and found the medicine available for purchase. Blagojevich said the vaccines could be "shipped within hours of approval by the FDA.''

 The Illinois Department of Public Health, according to a release from the state, evaluated the ingredients of the vaccines and concluded that the medicine "contains the identical properties as the Aventis vaccine produced for the United States.''

 State personnel did not inspect the Lyons plant. Blagojevich in his letter to Crawford urged the FDA to decide if inspections are needed and, if so, "conduct them immediately.''

Shortage factors into campaign

 Stories about seniors and others standing in long lines for flu shots have run in the closing days of the presidential campaign. The political implications of the shortage grew sharper when President Bush and Sen. John Kerry were asked about the flu shortage in the final presidential debate.

 Bush urged younger people not to get the shot in order to save supplies for at-risk populations, including almost all senior citizens. He blamed the cost of lawsuits for driving U.S. manufacturers out of the flu vaccine business. Last week, Bush signed a measure that gave limited liability protection to flu manufacturers.

 Kerry is running a TV ad in some battleground states blaming Bush for the shrinking supply. "Instead of fixing the problem, production of the vaccine was sent to a factory overseas,'' the Kerry spot said. "Now Bush wants Canada to help, even though his own policies make it illegal for us to import medicine from Canada.''

 Blagojevich and Rep. Rahm Emanuel (D-Ill.) have led the fight to make legal imports of prescription drugs from Canada and other countries. The FDA and the Bush White House have resisted, on the grounds that the government will not be able to guarantee the safety of the medicine.

Origins of problem

 The flu vaccine crisis started Oct. 5 when the British government suspended the license of Chiron Corp., which was to have produced between 46 to 48 million doses of Fluvirin, about half of the supply for the U.S. market. The British suspected possible microbial contamination, and on Oct. 15 FDA inspectors visited the Chiron plant in Liverpool and determined none of the vaccine made there was safe to use.

 In addition to seeking approval to use the French flu vaccine, Blagojevich is asking the CDC to allow Illinois to use federal funds to pay for the medicine. If turned down, the governor will use state money.

 Abby Ottenhoff, a Blagojevich spokesman, said if more doses are located, the state would seek to distribute the medicine to hospitalized children.

BY PAUL H.B. SHIN
DAILY NEWS STAFF WRITER

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