Vaccine protection added to Defense Bill

[Guest guest]

People should be outraged that the legislative process is allowed to

function in this way!!!

McNulty

Thursday, 02/09/06

Hastert, Frist said to rig bill for drug firms

Frist denies protection was added in secret

By BILL THEOBALD

Gannett News Service

WASHINGTON Senate Majority Leader Bill Frist and House Speaker

Dennis Hastert engineered a backroom legislative maneuver to protect

pharmaceutical companies from lawsuits, say witnesses to the pre-

Christmas power play.

The language was tucked into a Defense Department appropriations bill

at the last minute without the approval of members of a House-Senate

conference committee, say several witnesses, including a top

Republican staff member.

In an interview, Frist, a doctor and Tennessee Republican, denied

that the wording was added that way.



Trial lawyers and other groups condemn the law, saying it could make

it nearly impossible for people harmed by a vaccine to force the drug

maker to pay for their injuries.

Many in health care counter that the protection is needed to help

build up the vaccine industry in the United States, especially in

light of a possible avian flu pandemic.

The legislation, called the Public Readiness and Emergency

Preparedness Act, allows the secretary of Health and Human Services

to declare a public health emergency, which then provides immunity

for companies that develop vaccines and other " countermeasures. "

Beyond the issue of vaccine liability protection, some say going

around the longstanding practice of bipartisan House-Senate

conference committees' working out compromises on legislation is a

dangerous power grab by Republican congressional leaders that

subverts democracy.

" It is a travesty of the legislative process, " said Mann,

senior fellow at the Brookings Institution, a Washington think tank.

" It vests enormous power in the hands of congressional leaders and

private interests, minimizes transparency and denies legitimate

opportunities for all interested parties, in Congress and outside, to

weigh in on important policy questions. "

At issue is what happened Dec. 18 as Congress scrambled to finish its

business and head home for the Christmas holiday.

That day, a conference committee made up of 38 senators and House

members met several times to work out differences on the 2006 Defense

Department appropriations bill.

Rep. Obey, D-Wis., the ranking minority House member on the

conference committee, said he asked Sen. Ted s, R-Alaska, the

conference chairman, whether the vaccine liability language was in

the massive bill or would be placed in it. Obey and four others at

the meeting said s told him no. Committee members signed off on

the bill and the conference broke up.

A spokeswoman for s, Boone, said last week that the

vaccine liability language was in the bill when conferees approved

it. s was not made available for comment.

During a January interview, Frist agreed. Asked about the claim that

the vaccine language was inserted after the conference members signed

off on the bill, he replied: " To my knowledge, that is incorrect. It

was my understanding, you'd have to sort of confirm, that the vaccine

liability which had been signed off by leaders of the conference,

signed off by the leadership in the United States Senate, signed off

by the leadership of the House, it was my understanding throughout

that that was part of that conference report. "

But Kennedy, who works for Sen. Thad Cochran, R-Miss., as staff

director for the Senate Appropriations Committee, said at a seminar

for reporters last month that the language was inserted by Frist and

Hastert, R-Ill., after the conference committee ended its work.

" There should be no dispute. That was an absolute travesty, " Kennedy

said at a videotaped Washington, D.C., forum sponsored by the Center

on Congress at Indiana University.

" It was added after the conference had concluded. It was added at the

specific direction of the speaker of the House and the majority

leader of the Senate. The conferees did not vote on it. It's a true

travesty of the process. "

After the conference committee broke up, a meeting was called in

Hastert's office, Kennedy said. Also at the meeting, according to a

congressional staffer, were Frist, s and House Majority Whip

Roy Blunt, R-Mo.

" They (committee staff members) were given the language and then it

was put in the document, " Kennedy said.

About 10 or 10:30 p.m., Democratic staff members were handed the

language and told it was now in the bill, Obey said.

He took to the House floor in a rage. He called Frist and Hastert " a

couple of musclemen in Congress who think they have a right to tell

everybody else that they have to do their bidding. "

Rep. Dan Burton, R-Ind., also was critical of inserting the vaccine

language after the conference committee had adjourned.

" It sucks, " he told Congress Daily that night.

Rep. Jim Moran, D-Va., another member of the conference committee,

was upset, too, a staff member said, because he didn't have enough

time to read the language. The final bill was filed in the House at

11:54 p.m. and passed 308-102 at 5:02 the next morning.

The Senate unanimously approved the legislation Dec. 21, but not

before Senate Democrats, including several members of the conference

committee, bashed the way the vaccine language was inserted.

" What an insult to the legislative process, " said Sen. Byrd, D-

W.Va., a member of the conference committee. Byrd is considered the

authority on legislative rules and tradition.

President Bush signed the legislation into law Dec. 30.

When asked about Frist's earlier denial, spokeswoman Amy Call said:

" Bill Frist has fought hard to protect the people of Tennessee and

the people of the United States from a bioterror emergency and that's

what he did throughout this process. "

Hastert's office did not provide a response.

Not against the rules

The practice of adding to a compromise bill worked out by bipartisan

House-Senate conference committees, while highly unusual, is not

thought to violate congressional rules.

Some Senate and House Democrats have proposed banning the practice as

part of broader attempts at ethics reform in Congress.

They, consumer groups and others with concerns about possible harm

caused by vaccines charge that the move was a gift by Frist to the

pharmaceutical industry, which they point out has given a lot of

campaign cash to the Nashville doctor through the years.

" The senator should be working to ensure there are safe vaccines to

protect American families rather than protecting the drug industry's

pocketbooks, " Pamela Gilbert, president of Protect American Families,

said in a statement. The group is an alliance of consumer, labor and

advocacy organizations.

Frist has received $271,523 in campaign donations from the

pharmaceutical and health products industry since 1989, according to

the Center for Responsive Politics, a watchdog group.

He is also a possible candidate for president in 2008.

In the interview, Frist reiterated how important he thinks the

vaccine protections are.

" The United States of America, if a pandemic occurs, is totally

unprepared, " he said. " And the only way we are going to be prepared

is rebuilding our manufacturing base to build a vaccine

infrastructure that can be timely and responsive. We don't have it

today. "

Frist has long advocated liability protection for vaccine makers, and

it was widely reported that he would attempt to attach the

legislation to the Defense Appropriations bill because it is

considered must-pass legislation.

Ken , senior vice president of the Pharmaceutical Research and

Manufacturers of America, said that, while the group favors liability

protection, it did not take a position nor did it lobby on behalf of

the law that passed.

Senate Majority Leader Bill Frist

House Speaker Dennis Hastert

 About the law

The new law providing vaccine makers with protection against lawsuits

is called the Public Readiness and Emergency Preparedness Act.

Among its key provisions are:

? It allows the secretary of Health and Human Services to issue a

declaration that a " disease or other health condition or other threat

to health constitutes a public health emergency. "

? The secretary may also issue a declaration if there is a " credible

risk " that there may be such a problem in the future.

? The protection against lawsuits then kicks in covering the

" manufacture, testing, development, distribution, administration or

use of one or more countermeasures, " a term that includes vaccines

and other drugs.

? Requires someone who is injured to prove " willful misconduct, " and

states that the standard will be " more stringent than a standard of

negligence in any form or recklessness. "

? Excludes any state or federal court from reviewing the secretary's

decisions under the law.

? GANNETT NEWS SERVICE

 On the Web

The Center on Congress at Indiana University is athttp://

congress.indiana.edu. Click on " News " item about media seminar, then

click on " Part Three " for video of staffer's comments.

 What's next?

Here's what could happen next regarding the vaccine liability

protection law:

? House and Senate Democrats have proposed changing the rules to

block votes on any provision that has not been approved by a

conference committee.

? Members of Congress could try to amend the vaccine law.

? The law's constitutionality could be challenged in court.

? GANNETT NEWS SERVICE

Contact Bill Theobald atwtheobal@....