Flu drug liability attached to DOD spending bill

DOD 2006 Appropriations Bill

Congress attached language to the 2006 Defense appropriations bill passed Dec. 22 that gives liability protection to manufacturers of flu vaccines.

The protection comes under a section providing $3.8 billion in funding for avian flu preparedness, which the House added to the Defense Department bill earlier this week.

Rep. David Obey (D-Wis.), speaking on the House floor, called the liability protection language outrageous and a giveaway to the pharmaceutical industry.

Obey said the language was “unilaterally and arrogantly inserted” into the DOD bill by Senate majority leader Bill Frist (R-Tenn.) and House Speaker Dennis Hastert (R-Ill.) late on Dec. 21 without any consultation with members of the joint House and Senate DOD conference committee.

The sweeping liability protection language gives the secretary of the Department of Health and Human Services a “very broad power, indeed, to ban lawsuits…[against] any drug, vaccine, medical device or other products useful in dealing with…a health emergency,” Obey said.

Frist said the section of the Defense appropriations bill that deals with avian flu extends only “limited [liability] protections to manufacturers, distributors and first responders so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed and administered."

Jim Greenwood, a former congressman from Pennsylvania who now serves as president and chief executive officer of the Biotechnology Industry Organization, said the new legislation “does not provide for the same level of liability protection that the industry received as part of the smallpox vaccine program passed by Congress two years ago. However, I am hopeful that the provisions passed in this bill will reduce the risk of frivolous lawsuits.”

Sen. Ted Kennedy (D-Mass.) said Congress has few higher priorities than preparing for a flu pandemic, but “the threat from this deadly disease has been compounded by our inattention and unwillingness to prepare.”

Speaking Dec. 21 during floor debate on the 2006 appropriations bill for HHS and the Labor and Education departments, Kennedy said that “Canada, Australia, Britain, Japan and other nations released [pandemic] plans long ago…[but] the Bush Administration has put out a plan for only one federal agency, a response plan for the Department of Health and Human Services.”

He added that the HHS strategy “is a critical first step, but even that plan is incomplete. It’s missing operational plans for responding to a pandemic.”

President Bush had requested $7 billion to battle a potential avian flu pandemic, but Congress cut the funding almost in half in the DOD bill, which Kennedy called irresponsible.

Sen. Richard Durbin (D-Ill.) said one of the more striking failures of the spending bill Congress passed for HHS, Labor and Education is “the utter lack of concern over preparing for avian flu.” The bill includes $120 million in cuts for already underfunded programs at the Centers for Disease Control and Prevention to prepare for a pandemic, he added.