A Government Accountability Office report released Tuesday detailed HHS missteps, including losing tens of millions of dollars on expiring vaccines and awarding a $877 million contract that the agency canceled after an unproven pharmaceutical company called VaxGen failed to meet what HHS acknowledges were unrealistic expectations for a new vaccine.
The report drew rebukes at a Senate Homeland Security and Governmental Affairs hearing on bioterrorism preparation, held to coincide with the sixth anniversary of anthrax attacks that killed six people in 2001.
"The Department of Health and Human Services' efforts to develop a second generation anthrax vaccine -- to improve upon the 30-year-old-technology we have in the stockpile -- has, in a word, failed," Senate Homeland Security and Governmental Affairs Chairman Joseph Lieberman, I-Conn., said in an opening statement. "This is a disappointing failure that has put us back at square one after years of work."
Gerald Parker, principal deputy assistant secretary in HHS' office of the assistant secretary for preparedness and response, observed that anthrax vaccines are only one piece of efforts by HHS and the Homeland Security Department to prepare for biological threats through their $5.6 billion BioShield project.
Recognizing that it had been contracting too early in the risky drug development process, the agency is working to buy vaccines that are "further down the pipeline," Parker said.
For commercial markets, drug makers often raise capital to pay for development costs. But with no private market for biodefense products, big pharmaceutical companies have not competed for contracts to sell vaccines to the government, causing agencies to rely on smaller, less risk-averse companies.
According to GAO, established drug-makers have also stayed away because a lack of clear requirements from government departments places additional risks on contractors. Lieberman agreed with those sentiments. "We have to find a way to entice the big pharmaceutical companies to get into this," he said.
Parker said $189 million in the president's fiscal 2008 budget request for advanced drug development will spur needed research. The Biodefense and Pandemic Vaccine and Drug Development Act of 2006 calls for advanced biodefense research, but Congress thus far has not funded the so-called BARDA Act.
Tara O'Toole, director of the Center for Biosecurity at the University of Pittsburgh Medical Center, said the gap between the government's goals for guarding against biological terrorism and its spending is much larger than most involved realize. "Five billion [dollars] is much less than we're going to need," O'Toole said.