The US Senate plans to offer new incentives to the pharmaceutical and biotech industries to develop more vaccines, drugs, and countermeasures against a range of pathogens. Prominent among the biodefense measures before Congress is the Biodefense and Pandemic Vaccine and Drug Development Act (S. 1873). The bill, authored by Sen. Richard Burr (R-NC), would establish a new government agency – the Biomedical Advanced Research and Development Agency – to fund and coordinate government R&D efforts into countermeasures for bioterrorism and natural outbreaks. The bill would offer liability protection for vaccine manufacturers and a 10-year marketing exclusivity for companies producing countermeasures, during which time competitors could not produce generic substitutes.

While the brand-name drug and biotech industries and lawmakers from both parties support the bill, some generic drug manufacturers, consumer groups, and healthcare insurers say the exclusivity provisions will increase prescription drug costs. Some Democrats believe the bill provides too much immunity for vaccine manufacturers. "There are some concerns," acknowledges Burr's spokesperson, Doug Heye.

"It's not a bailout," says Frank Rapoport, managing partner at McKenna Long & Aldridge, a law firm representing drug companies seeking government contracts. "Pharmaceutical companies can be sued if fraud is committed in the FDA application process, but otherwise, companies and the government are immune from lawsuits," he says.

Separately, President Bush outlined a $7.1-billion national strategy in a Nov. 1 speech at the National Institutes of Health to expand domestic vaccine production capacity, detect and respond to influenza outbreaks, and stockpile treatments against the H5N1 avian influenza A virus. Bush is seeking $2.8 billion to develop cell-culture technologies to give companies the "surge capacity" to rapidly produce pandemic flu vaccines. The goal is to produce enough vaccine for every American within six months of an outbreak by "bringing cell-culture technology from the research laboratory into the production line" by 2010, Bush says. Citing the "growing burden of litigation," the president also urged Congress to pass liability protection to encourage vaccine manufacturers to return to this market.