The New York Times
WASHINGTON, DC — Companies making vaccines to protect against biological agents or pandemic viruses would be shielded from lawsuits, even if they are negligent or reckless, under a provision inserted into a military spending bill by Senator Bill Frist of Tennessee, the majority leader.
Reviving the nation’s flagging vaccine industry is a long-held goal of Mr. Frist, a heart-lung transplant surgeon who has made health care legislation the centerpiece of his Senate career. In a meeting with reporters Saturday night, Mr. Frist described the provision, which was added to the bill produced by a House-Senate conference committee, as one that offered drug makers ”targeted liability protection.”
Aides to Mr. Frist said the measure was more restrictive than the existing law offering immunity to companies that produced smallpox vaccine; in the case of smallpox, the vaccine makers could not be sued for any reason. The language in the pending military bill, by contrast, permits suits for ”willful misconduct,” though it specifies that willful misconduct does not include negligence or recklessness.
But critics, like Senator Edward M. Kennedy, Democrat of Massachusetts, said the language was more far-reaching than Mr. Frist had described.
”The Republican leadership in Congress cut a back room deal to give a massive Christmas bonus to the drug companies,” Mr. Kennedy said in a statement.
In an interview, Mr. Kennedy said he would try to strip the language from the bill, arguing that it was not relevant to the military measure.
The immunity provision has already been approved by the House, which voted early Monday to pass the military spending measure.
The provision would provide immunity from lawsuits to any company that made ”countermeasures” — broadly defined as drugs, vaccines or medical devices — to protect Americans against pandemics, epidemics or biological attacks. It would give the secretary of health and human services authority to determine what constituted a pandemic or an epidemic.
Critics said that authority, broadly construed, could apply to heart drugs or diabetes, for example, should the secretary declare heart disease or diabetes an epidemic.
The language also permits the government to pay medical expenses, disability benefits and death benefits to those injured by the products it covers. Mr. Frist said the compensation program was essential to encouraging the development of drugs and vaccines.
”To establish a viable, dynamic manufacturing base, it is absolutely critical that we give very targeted liability protection, coupled with a fair compensation package,” he said.
The action enraged House Democrats. Representative David R. Obey of Wisconsin, the senior Democrat on the Appropriations Committee, said Republican colleagues had assured him that the immunity provision would not be included in the House-Senate conference report on military spending.
An outside advocacy group, the Foundation for Taxpayer and Consumer Rights, said the provision posed a conflict of interest for Mr. Frist and 41 other senators who, it said, own as much as $16 million in pharmaceutical stock. A spokeswoman for the group, Carmen Balber, called the provision ”a giveaway deal that half the Senate cannot ethically participate in.”
