GOP Wants to Create Secretive Gov't Agency (for drugs)

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GOP Wants to Create Secretive Gov't Agency

By ANDREW BRIDGES, Associated Press Writer

December 2, 2005

 

WASHINGTON (AP) - By creating a federal agency shielded from public

scrutiny, some lawmakers think they can speed the development and

testing of new drugs and vaccines needed to respond to a bioterrorist

attack or super-flu pandemic.

 

The proposed Biomedical Advanced Research and Development Agency, or

BARDA, would be exempt from long-standing open records and meetings

laws that apply to most government departments, according to

legislation approved Oct. 18 by the Senate health committee.

 

Those exemptions would streamline the development process, safeguard

national security and protect the proprietary interests of drug

companies, say Republican backers of the bill. The legislation also

proposes giving manufacturers immunity from liability in exchange for

their participation in the public-private effort.

 

" We must ensure the federal government acts as a partner with the

private sector, providing the incentives and protections necessary to

bring more and better drugs and vaccines to market faster,'' Sen.

Richard Burr, R-N.C., said when the Committee on Health, Education,

Labor and Pensions approved the bill.

 

The agency would provide the funding for development of treatments and

vaccines to protect the United States from natural pandemics as well

as chemical, biological and radiological agents.

 

But it is the secrecy and immunity provisions of the legislation that

have alarmed patient rights and open government advocates. The agency

would be exempt from the Freedom of Information and Federal Advisory

Committee acts, both considered crucial for monitoring government

accountability.

 

" There is no other agency that I am aware of where the agency is

totally exempt either from FOIA or FACA,'' said Pete Weitzel,

coordinator of the Coalition of Journalists for Open Government. The

coalition is an alliance of journalism groups, including the American

Society of Newspaper Editors and Associated Press Managing Editors,

that wrote to lawmakers seeking amendments to the bill. " That is a

cause for major concern and should raise major policy concerns,''

Weitzel said.

 

Burr spokesman Doug Heye said the provisions would keep competitors

from gaining proprietary information through FOIA. However,

confidential business information already is exempt from FOIA.

 

" There's no secrecy involved in BARDA,'' Heye said. " That is

absolutely false. This is an agency that will be putting out

information daily.''

 

Some Democrats question whether the public would accept drugs or

vaccines developed in conjunction with the agency, citing the abortive

2003 effort to vaccinate 500,000 front-line health care workers

against smallpox. Only about 40,000 workers ultimately received the

vaccine amid concerns about the vaccine's safety, which health

authorities initially downplayed.

 

" Republican leaders in Congress are now proposing a plan that would

make exactly the same mistake,'' Sen. Chris Dodd, D-Conn., said in a

statement. " Their plan will protect companies that make ineffective or

harmful medicines, and because it does not include compensation for

those injured by a vaccine or drug, it will discourage first

responders and patients from taking medicines to counter a biological

attack or disease outbreak.''

 

The bill does provide for limited compensation. However, another

provision would grant drug companies immunity unless " willful

misconduct'' can be shown.

 

The Pharmaceutical Research and Manufacturers of America said it was

reviewing the bill. Another industry group, the Biotechnology Industry

Organization, declined comment.

 

The National Vaccine Information Center, an advocacy group, called the

legislation " a drug company stockholder's dream and a consumer's worst

nightmare.''

 

The proposed law comes amid growing concern about pandemics and the

government's ability to meet such threats. For instance, the United

State needs another three to five years to develop the manufacturing

capacity to produce 300 million doses of flu vaccine, Health and Human

Services Secretary Mike Leavitt said Sunday on NBC's " Meet the Press.''

 

The agency would improve on Project BioShield, a barely two-year-old

program also meant to encourage production of vaccines and drugs, Heye

said.

 

" While some progress has been made, we still haven't seen the

participation from companies, universities and research institutions

in developing vaccines we might need to protect us from the next

threat, whatever that might be,'' Heye said. " One of the reasons is

(they) don't want to put their very existence on the line.''

 

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,

said the agency as proposed would represent a setback to decades of

progress in opening up to the public the process of testing the safety

and efficacy of drugs.

 

" These provisions are extremely dangerous,'' Wolfe said. " The fact

that they are being proposed, really exploiting people's fears about

pandemics and epidemics, is outrageous and goes backward on the

progress on the use of the Freedom of Information Act and Federal

Advisory Committee Act to increase public scrutiny and increase the

correctness of decisions that are made.''

 

Republican and Democratic lawmakers alike agree the drug industry

needs some protections to encourage it to produce emergency stocks of

vaccines and drugs, but Democrats have balked at providing blanket

immunity without first establishing a compensation fund for patients.

 

Republicans are pushing for liability protections for vaccine

manufacturers on other fronts as well. Senate Majority Leader Bill

Frist, R-Tenn., is seeking to add such protections to a defense

appropriations bill.

 

Frist spokeswoman Amy Call said drug company concerns about liability

are real.

 

" There's really no financial incentive for them to get into the

market, sell to the government at a reduced rate and then open

themselves up to losses that could potentially bankrupt them,'' Call said.

 

The push for liability exemptions may force the Burr bill to the

sidelines until the next session of Congress, Republican and

Democratic aides said. But Call said Frist intends to pursue the

legislation.

 

On the Net:

 

Information on the bill, S. 1873, can be found at

http://thomas.loc.gov/ (PROFILE (COUNTRY:United States;

ISOCOUNTRY3:USA; UNTOP:021; APGROUP:NorthAmerica;)

 

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