FDA Warns Maker of Anthrax Vaccine
By Justin Gillis
Washington Post Staff Writer
Wednesday, April 5, 2006; Page D01
http://www.washingtonpost.com/wp-dyn/content/article/2006/04/04/AR2006040401725.html
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.