http://www.biomedcentral.com/news/20030516/06

BioShield moving forward

Unlimited spending authority and industry liability remain key stumbling blocks

By Ted Agres
 

A House of Representatives committee has approved legislation to enact Project BioShield, the White House plan to accelerate development and production of new vaccines and countermeasures against biological weapons. But the committee has rejected the Bush administration's request for unlimited funding authority, a component that officials argue is essential to spur research and development of new vaccines and therapeutics.

The House Energy and Commerce Committee on Thursday unanimously approved its version of the Project BioShield Act and set funding at around $5.6 billion over the next 10 years. The House bill is at odds with the Senate version, which grants the administration's request for "permanent indefinite funding authority" to spur development and purchase "huge amounts" of vaccines or drugs to treat smallpox, anthrax, Botulinum toxin, Ebola, plague, and other pathogens.

That measure (S 15), passed March 19 by the Senate Health, Education, Labor and Pensions (HELP) Committee, would authorize a permanent funding stream of around $6 billion for 10 years. Completion of Project BioShield legislation is still distant because the House Committee on Homeland Security will also consider the matter, and any differences between the House and Senate versions will need to be resolved.

The White House maintains that unrestricted funding authority is needed to assure biotech and pharmaceutical companies that the government will buy their vaccines and other products. "These companies clearly need some assurances that there will ultimately be a return for their investment," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID). "They do not want to be vulnerable to the vicissitudes of the cyclical appropriations process," he explained during congressional testimony in April.

But House members from both political parties have expressed doubts about this approach. Energy and Commerce Committee ranking member John Dingell (D-Mich.) termed the unrestricted funding concept "an unlimited, unfettered future blank check" during a hearing in March. Rep. Henry Waxman (D-Calif.) said the approach "could be looked at as an abdication of congressional responsibility."

Following Thursday's vote, committee Chairman Rep. Billy Tauzin (R-La.) told Reuters, "We're trying to give [Bush] as much as we can without surrendering the balance of power" between Congress and the president.

"It's not surprising that they attempted to write an appropriation for a fund that reserves the power of the purse of Congress," said Janet Shoemaker, director of public and scientific affairs for the American Society for Microbiology. The specifics on managing a 10-year appropriation that the president can tap into while maintaining congressional oversight have not been seen, she said. "The question is, how will it operate?"

Project BioShield would give the National Institutes of Health (NIH) new authority to bypass traditional procedures when awarding urgently needed research and development grants and contracts. It would also give the Food and Drug Administration (FDA) ability to authorize widespread use of experimental drugs in case of a bioterrorist attack or other emergency.

Neither the House nor the Senate bills contain liability and compensation provisions sought by the pharmaceutical industry to protect against claims from those who are harmed by vaccines or other products used in an emergency. Tauzin said he would have supported such provisions but recognized it would have bogged down the legislation in political wrangling. HELP Committee Chairman Judd Gregg (R-NH) removed similar compensation language from the Senate bill in March in the face of opposition from Senator Edward Kennedy (D-Mass.).

Tommy Thompson, secretary of the Department of Health and Human Services (HHS), maintains that companies would be adequately protected through language already contained in the BioShield legislation. But the pharmaceutical industry is not convinced and is pressing for liability protection similar to that mandated for smallpox. Industry leaders also are seeking explicit exemptions from antitrust violations should they collaborate and cooperate in BioShield research programs.

A BioShield budget resolution (H.Con. Res. 95), approved in March by House and Senate budget committees, authorizes $890 million for fiscal year (FY) 2004 and $5.59 billion in outlays from FY 2004 through FY 2013. The nonbinding measure offers guidance to congressional appropriators.

In a related matter, two prominent senators have urged the administration to use funds from BioShield instead of the NIH budget to purchase quantities of second-generation anthrax vaccine. A debate over the word "procurement" has triggered a dispute between Congress and the administration, with legislators refusing to authorize $250 million needed to purchase the vaccine. NIAID could be left holding the bag, forced to use funds that otherwise would have gone for research.

Senators Arlen Specter (R-Penn.) and Tom Harkin (D-Iowa), chair and ranking minority member of the Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, are urging Office of Management and Budget (OMB) Director Mitch Daniels to use BioShield funds for the anthrax procurement.

"Rather than diverting funds appropriated for SARS, AIDS, and other infectious disease research at the NIAID, would it not be more appropriate to use funds that will be made available in the BioShield bill to purchase the anthrax vaccine?" they asked in a recent letter to Daniels.