Washington Editor

WASHINGTON - President Bush Tuesday called for a $7.1 billion plan to fight pandemic influenza.

"Our country has been given fair warning of this danger to our homeland, and time to prepare," he said in a speech at the National Institutes of Health, where he unveiled some particulars of the National Strategy for Pandemic Influenza. "It's my responsibility as the president to take measures now to protect the American people from the possibility that human-to-human transmission may occur."

The plan includes $2.8 billion to speed the development of cell-culture techniques for improved vaccine production, to ensure enough for every American within six months of the start of a pandemic, and another $1.2 billion for the government to buy enough vaccine against the current avian flu strain to protect 20 million Americans. Bush also called for $1 billion to stockpile more antivirals such as Tamiflu (oseltamivir, from F. Hoffmann-La Roche Ltd.) and Relenza (zanamivir, from GlaxoSmithKline plc).

"By making wise investments in technology and breaking down barriers to vaccine production, we're working toward a clear goal," he said. "In the event of a pandemic we must have enough vaccine for every American."

Clearly, the drug industry has benefited financially from early government efforts related to bird flu, such as the $62.5 million contract just awarded to Emeryville, Calif.-based Chiron Corp. to produce vaccine for the H5N1 strain. Similarly, Sanofi-Aventis in Lyon, France, has a $100 million H5N1 vaccine contract. Following President Bush's multi-billion-dollar pledge came a flood of other company statements commenting on their own bird flu research.

Roche, of Basel, Switzerland, has pledged "to do our part in ensuring preparedness in the U.S.," said George Abercrombie, the president and CEO of Hoffmann-La Roche Inc. That company's recent efforts have been aimed at increasing Tamiflu production, both through internal manufacturing improvements and by way of external contracts.

In addition to procurement measures, Bush's strategy also benefits drug makers in addressing regulatory and other legal barriers to expand the domestic vaccine production capacity, although he did not discuss specifics.

"Congress must pass liability protection," he said after calling the growing burden of litigation "one of the greatest obstacles to domestic vaccine production."

All such provisions were applauded by the Biotechnology Industry Organization.

"The President's proposal certainly has all the elements that we were interested in," said Amit Sachdev, BIO's executive vice president for health. He highlighted the plan's funding for research and development, procurement and stockpiling, as well as for the not-yet-approved H5N1 vaccine and for improving cell-culture technology. Sachdev also praised Bush's call for liability protection and overcoming regulatory hurdles, although he noted that BIO would await transparency on those provisions' finer points.

Still, Bush's plan has its share of critics, led by Sen. Barack Obama (D-Ill.). He lauded the President's overall intent Tuesday, but questioned a few of its provisions. Of note, the first-term lawmaker said the government ought to spend more on antivirals, as outlined in a $7.9 billion emergency appropriation that has passed in the Senate, and less on cell-culture technology.

"That is a good idea," Obama said of cell-culture techniques during a news conference at the Capitol, "but we may not want to take the money from Peter to pay Paul." He also was wary of broad liability protections, saying that the vaccine market's size is a reflection of low profit margins rather than a function of litigation concerns.

Criticism also fell more along party lines, as at the same news conference, Sen. Hillary Clinton (D-N.Y.) questioned the administration's capability to manage the situation, given past seasonal flu missteps under its watch, and said "the president has come late to the party" after a year of Capitol Hill talks and hearings on bird flu.

Also, Sen. Tom Harkin (D-Iowa) said the House of Representatives ought to fund bird flu preparedness measures through an emergency financing vehicle like the Senate, rather than continuing to explore the issue in terms of offsetting the funds from another allocation such as Medicare. Additional criticism questioned the amount of vaccines and antivirals to be stockpiled under the President's plan.

Appropriation committees in both chambers are holding meetings on the matter today, a speedy response cheered by Sachdev.

While Bush reminded listeners that as of yet "there is no pandemic influenza in the United States or the world," the federal government's plan underscores the urgency of the matter that has surfaced in recent weeks. To date, the H5N1 virus has infected birds in 16 countries and caused 200 million bird deaths across Asia, while Obama noted that preliminary tests have found the virus in Canadian ducks this week. At the same time, the highly lethal virus is known to have infected 121 people in four countries, resulting in 62 deaths over the past two years.

Bush's plan also includes a range of broader initiatives. Going forward, the Department of Health and Human Services is to lead the nation's medical response, the Department of Agriculture will head a veterinary response, international activities will be coordinated by the Department of State and the Department of Homeland Security will oversee domestic incident management and federal coordination.

The strategy earmarks funds for states and local governments to prepare area-specific emergency plans, and calls for observational improvements to be spurred in part by the National Biosurveillance Initiative and the International Partnership on Avian and Pandemic Influenza as part of the Administration's preparedness efforts.

The overall strategy also calls for vaccines to control outbreaks in bird populations, international partnerships and military-imposed quarantines.

"By making critical investments today, we'll strengthen our ability to safeguard the American people in the awful event of a devastating global pandemic," Bush said, "and at the same time, we'll bring our nation's public health and medical infrastructure more squarely [into] the 21st century."