By The Hill Staff - 10/12/05 12:00 AM EDT
Rising worry about a bird-flu pandemic is reviving drug-company hopes for legal protections to produce vaccines.
The debate once centered on preparations for a terrorist attack that released deadly strains of anthrax or smallpox. But the administration and lawmakers are now rushing to prepare for a global flu outbreak that medical experts say is almost sure to happen.
The Senate already has approved an amendment offered by Sen. Tom Harkin (D-Iowa) that added $3.9 billion to the military spending measure to prepare for the flu. The money will be used to stockpile medications to combat the flu.
Lobbyists from pharmaceutical companies say a critical component of any effort is immunity from lawsuits if a vaccination causes harm.
Without new legal safeguards, pharmaceutical companies are unlikely to produce vaccines, a business that offers little reward but a lot of risk, lobbyists say.
“Vaccines are not Viagra,” said John Clerici of McKenna, Long and Aldridge, which represents Sanofi Pasteur, a French company that has a vaccine-manufacturing plant in Pennsylvania, and other pharmaceutical companies.
“You aren’t going to make a huge amount of money making vaccines.”
This month, the Department of Health and Human Services awarded Sanofi a $97 million contract to develop a new type of flu vaccine.
But a deterrent for wider participation among the industry is the potential liability, which Clerici said is huge because the number of people who would use a vaccine in a global outbreak likely will reach in the hundreds of millions.
The debate over liability protection pits two rival lobbying powers against one another once again: drug companies and trial lawyers.
The Association of Trial Lawyers of America (ATLA) opposes “efforts by some in Congress and their friends in the pharmaceutical industry to use the threat of outbreak as means to provide big giveaways to special interests,” said ATLA spokeswoman Chris Mather.
The association instead favors reforming the Vaccine Injury Compensation Program, which set up a federal, court-like process through which alleged victims of vaccination could seek financial compensation.
Created in 1986, the program has settled 1,200 vaccine claims worth $1.2 billion as of 2004. But it has come under criticism for being too slow in giving victims redress.
Recent battles over liability protection were fought as Congress debated Project Bioshield, an effort by the White House to develop “medical countermeasures” to biological and chemical terrorist attacks.
After liability protection for makers of thimerosal, a vaccine component some say may be linked to a rising incidence of autism, was attached to the 2002 homeland-security bill in the dead of night — it was later removed — Congress had little appetite to attach liability protections to Bioshield when it passed the act in 2004.
But as the so-called bird flu spreads around the globe, though it has killed relatively few humans, Congress and the administration have taken new interest in vaccine development.
Last week’s news that the 1918 pandemic that killed at least 50 million people was a mutated avian strain transferable by human-to-human contact has provided additional momentum.
Several lawmakers have introduced bills or are drafting them to improve the system for producing and distributing vaccines — both for flu outbreaks and biological attacks.
Sens. Hillary Rodham Clinton (D-N.Y.) and Pat Roberts (R-Kan.), for example, last week introduced the Influenza Vaccine Security Act.
The bill’s provisions include shifting the liability from pharmaceutical companies to the federal government for “personal injury or death resulting from the manufacture, administration or use of qualified pandemic influenza technologies.”
Mather said ATLA was still reviewing the bill. Chiron, the flu-vaccine maker, is listed as a supporter of the bill.
Sen. Richard Burr (R-N.C.), who is chairman of the Senate Health Committee’s Bioterrorism and Public Health Preparedness Subcommittee, has said he will introduce a broad measure next week to prepare for a bioterrorism or flu outbreak.
Doug Heye, a spokesman for Burr, said the bill, which is still being drafted, is likely to borrow from a bill already introduced by Sen. Judd Gregg (R-N.H.) that provides drug companies with liability protection.
“We need to provide incentives to companies to bring drugs and vaccines to the marketplace,” Heye said.
Participation in Bioshield has so far been disappointing. Congress made available $5.6 billion to drug companies to develop new drugs or vaccines. But Clerici said only three contracts, worth a total of around $1 billion, have been awarded.
Drug companies have “not participated at a level anticipated after Bioshield,” Heye acknowledged.
But Mather noted news reports suggesting more companies are interested in producing vaccines, even without liability protection.
Executives from pharmaceutical giants like GlaxoSmithKline and Wyeth have announced investments in vaccine production facilities, Maher said.