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FDA Warns Maker of Anthrax Vaccine

By Justin Gillis
Washington Post Staff Writer
Wednesday, April 5, 2006; Page D01

Federal drug regulators have accused a California company of breaking the law by making exaggerated claims about the purity and effectiveness of a new vaccine for anthrax, a fresh blow for a troubled $1 billion program at the center of the government's plans to counter bioterrorism.

In a letter made public yesterday, the Food and Drug Administration accused VaxGen Inc. of making "false or misleading statements" about the vaccine, essentially by offering rosy interpretations of the handful of scientific studies that have been completed on the product.

The agency specifically cited a promotional document the company handed out in Washington in October that claimed the company's techniques allowed it to produce a vaccine "at nearly 100% purity" and asserting that the product generates immunity comparable to that induced by an older vaccine. Neither claim is warranted on the basis of early research, the FDA declared.

The statements in the VaxGen document closely resemble assertions the company has made in regulatory filings and in public meetings over the past two years. The FDA threatened court action unless VaxGen devises a plan to "disseminate truthful, non-misleading, and complete information" about the vaccine to anyone who might have received such puffed-up claims, an audience that may well include thousands of individual stockholders.

Though the letter was made public only yesterday, VaxGen received it March 24 and neither disseminated it nor filed any disclosure about it with the Securities and Exchange Commission. Paul Laland, a VaxGen spokesman, said the company did not feel such disclosure was warranted. "Based on our internal assessment and research of industry standards, we did not believe this was material information," he said.

He added that VaxGen was still reviewing the FDA letter and could not comment at length on the agency's assertions.

"We'll review it internally, and we're going to respond, and if needed we'll put a plan together," Laland said. "If there is something that's incorrect, then we will take corrective action."

VaxGen has been struggling to fulfill $1 billion worth of federal contracts to make 75 million doses of anthrax vaccine, enough to immunize 25 million people, a population roughly the size of the combined New York and Washington metropolitan areas. The vaccine would most likely be used after a large-scale anthrax attack to immunize people exposed to the germ, whose spores can take months to germinate, causing a deadly lung infection.

The VaxGen contracts are the largest awarded to date under Project BioShield, President Bush's program to create defenses against biological and radiological attack. Members of Congress have complained sharply about delays and other problems in the way the Health and Human Services Department has handled that program, and HHS Secretary Mike Leavitt responded recently by promising improvements.

VaxGen has long had a troubled history, including accounting problems that the company has pledged repeatedly to fix but so far hasn't. The company has acknowledged that it is at least a year behind in producing the anthrax vaccine and will default on its contracts in November unless the government grants a time extension.