Will Congress Give Vaccine Makers a Shot in the Arm?

[Guest guest]

Will Congress Give Vaccine Makers a Shot in the Arm?

Marcia Coyle

The National Law Journal

12-16-2005

Fear of lawsuits, hostility toward trial lawyers, short-sightedness and

pandering to special interests are behind a Republican-led effort to enact

quickly unprecedented vaccine liability protection for drug manufacturers

and sellers with little or no compensation for injured victims in the event

of a pandemic flu outbreak, say a host of health, consumer, union and other

groups.

Many of those groups have joined together in an effort to force into the

open what have been closed-door negotiations by Senate and House Republicans

over a plan to attach the liability waiver to a pending Department of

Defense appropriations bill expected to pass both chambers before the year's

end.

" They are putting this provision on the Defense appropriation because they

know it's insufficient standing alone and that's how you get it through the

Congress, " said Barbara Coufal, legislative affairs specialist for the

American Federation of State, County and Municipal Employees. " I think that

speaks to the inadequacy of this one-sided approach. "

Democrats appear to be locked out of the negotiations in the Senate. Their

staffers and the groups' legislative directors have been unable to get

details of what's being proposed, other than the broad liability protection

for vaccine manufacturers. The groups themselves are divided on the need for

liability protection to encourage vaccine production, but they are united in

the belief that any liability protection must be coupled with a compensation

program if a vaccination effort is to succeed.

" [senate Majority Leader Bill] Frist says the industry needs this protection

in order to motivate it, " said Jillian Aldebron, civil justice counsel for

Public Citizen's Congress Watch. " It's not even true. They're all falling

all over each other to get into the bird flu business. The prospect of

global disease and big government purchases has them all salivating. "

" We're concerned about making sure that, like first responders, consumers

will have somewhere to turn if there is gross negligence and the like [in

vaccine production and use], " said Helen , policy director for

USAction.

" For Republican leadership to be moving forward with a very broad liability

waiver while doing nothing for first responders and consumers seems not the

proper way to do this, " she said. " You can do it quickly, but not in the

middle of night in a secret way. "

The nation's experience with vaccination programs, particularly the recent

and spectacular failure of the federal smallpox vaccination program, proves

the truth of what says, according to Greenberger of the

University of land School of Law, director of the university's Center

for Health and Homeland Security.

" It's a very, very complicated issue, " he said. " There is no doubt vaccine

manufacturers need sufficient liability protection, but it has to be

accompanied by a sophisticated and adequate compensation policy for those

injured by the vaccine. What's driving policymakers now is they fear and

dread the onset of attorneys bringing frivolous lawsuits. Certainly that can

be worked out in the compensation process. "

The federal government has implemented three major vaccine liability and

compensation programs in the last 30 years: the National Swine Flu

Immunization Program of 1976, the National Childhood Vaccine Injury

Compensation Act of 1986 and the so-called Phase I smallpox vaccination

program launched in 2003.

Fear of a swine flu pandemic surfaced in January 1976 when four cases of

swine flu were reported in New Jersey. Congress authorized the purchase of

about 200 million doses of the swine flu vaccine in April of that year.

But concerns about vaccine manufacturers' liability, according to

Greenberger, did not arise until insurers -- pointing to a federal court

decision holding polio vaccine manufacturers strictly liable for failing to

provide product warnings directly to consumers -- announced they would end

coverage in June of that year.

Congress responded with the Swine Flu Act, under which the United States

assumed the liability of manufacturers, distributors and vaccinators.

Injured parties filed their court claims against the government under the

Federal Tort Claims Act after first filing an administrative claim. The act

allowed the government to seek indemnification from negligent parties

covered by the liability protections. The act also did not limit the amount

of awards to injured claimants.

By 1985, the government had paid $90 million in awards to injured claimants

and thus began, said Greenberger, the government's increasing reluctance to

assume the financial risks in vaccination programs.

Congress got back into the vaccine business in the mid-1980s in response to

a decline in the number of manufacturers making childhood vaccines. However,

the lawmakers drafted a more limited liability and compensation policy under

the National Childhood Vaccine Injury Compensation Act than provided by the

Swine Flu Act.

NCVICA set up a two-stage compensation system for specific childhood

vaccines. In the first and mandatory stage, a federal court special master

administered no-fault compensation for specific injuries. Awards are capped

and the government is the defendant.

If dissatisfied with the administrative result, claimants could sue the

vaccine manufacturer in the tort system -- the second stage under NCVICA.

But Congress enacted certain liability protections for the manufacturers

here, such as immunity from punitive damages if they had complied with the

Federal Food, Drug and Cosmetic Act and the Public Health Service Act.

NCVICA also made compensation secondary to federal, state and private

sources of compensation.

In January 2003, the Bush administration launched the Phase I smallpox

vaccination program, designed to vaccinate 500,000 civilian first responders

with an existing smallpox vaccine.

The program initially relied on Section 304 of the Homeland Security Act of

2002 for liability protection and compensation. But it soon became clear, as

health care workers and unions balked at being vaccinated, that those

provisions were neither clear nor adequate to overcome first responders'

concerns that if injured by the vaccine, they would be compensated.

Congress worked on additional liability and compensation provisions over the

next few months. Ultimately, however, the program failed to achieve its

goal. Roughly 40,000 first responders out of the targeted 500,000 have been

vaccinated.

" The program sort of disappeared off the face of the earth, " said

Greenberger, who wrote about all three programs in a recent law review

article. " The overwhelming problem pre-event -- and vaccination for a flu

pandemic will need to be done pre-event -- is that health care unions don't

want to participate if they are not assured their workers will receive

adequate compensation if injured, " he said.

There are reports that the pandemic flu vaccine being developed appears to

be very effective, he said. The United States has ordered about 2 million

doses and the message is going out that hospital and health care workers

will have to be vaccinated.

" We are going to go through the exact thing again, as with smallpox, if

there's not an adequate compensation program, " said Greenberger. " The cost

of an adequate program is quite small compared to the public health benefits

to be derived. "

NO LIABILITY, NO MONEY

The focus of the behind-closed-door negotiations on pandemic flu vaccine

liability appears to be Section 6 of S. 1873, the Biodefense and Pandemic

Vaccine and Drug Development Act of 2005, sponsored by Senator Burr,

R-N.C.

Under that section, vaccine manufacturers are immune from any liability

except in the case of willful misconduct. And a willful misconduct claim is

determined by the secretary of the Department of Health and Human Services.

The bill would provide compensation for injured persons in accordance with

the compensation provisions of the small pox vaccination program.

But various Hill sources contend that Republican leaders are only preparing

the immunity side of the equation for amendment to the Defense

appropriations bill. And that section has been expanded to allow the

secretary to waive liability under certain emergency conditions.

" The immunity there is fairly broad, " said Joanne Doroshow of the Center for

Justice & Democracy. " It doesn't allow any lawsuit for gross negligence or

recklessness. In order for even a claim of intentional misconduct, the

secretary of HHS would have to designate it as such before a suit could go

forward and there's no compensation at all. "

The Burr bill itself is " problematic, " said AFSCME's Coufal, because it uses

the smallpox program as a compensation model. " We don't think that's

appropriate because it only covers first responders and health care

workers, " she said. " We think any compensation program has to cover the

entire public. "

Burr spokesman Doug Heye said his boss is still working with Democrats on a

bipartisan compromise on the bill that Burr hopes will be the Senate vehicle

because it represents a more comprehensive approach to a bioterror threat.

Republican leaders negotiating the liability provision may believe they can

deal with compensation later, said M. Mair of s Hopkins Bloomberg

School of Public Health. " With pandemic flu, the compensation issues might

be different. For smallpox, we wanted people to volunteer to be vaccinated.

You needed compensation. People probably will be rushing down the door to

get pandemic flu vaccine. It needs to be investigated, but I would not say

it's a definite component. "

But some question whether liability protection is necessary. " Is this what

is affecting vaccine production? " asked Doroshow. " Experts pretty

universally say this is not the reason. A study in the Journal of the

American Medical Association a month ago said liability has nothing to do

with this. The reasoning behind liability protection is a lot of hype,

anti-trial lawyer hype. "

Public Citizen's Aldebron agreed, adding that the industry already has

indemnification under Bush Executive Order 10789, which has been made part

of HHS' pandemic flu plan. " They're holding us hostage. Let's call their

bluff. "

The drug companies have been quiet on the negotiations. When Bush announced

a pandemic flu plan last month, drug manufacturers said liability protection

was essential. " The liability provision is not finished yet, so we're not

ready to say something, " said a spokesperson for the Biotechnology Industry

Organization.

Greenberger said that manufacturers are interested, but the country is not

going to get the amount of vaccine it needs quickly without liability

protection.

" With such hostility towards plaintiff litigation, that's a very hard thing

to sell, but I feel strongly the government needs to step in here, " he said.

" It can fight off frivolous lawsuits or have lawsuits dealt with in an

administrative process, but to say there is no compensation is asking for

trouble. "

-------------------------------------------------

Agency Would Be Exempt from FOIA

Last month, Sen. Burr (R-NC) introduced a bill which would create

the first -- and only -- government agency granted immunity from the Freedom

of Information Act (FOIA). The new bill, S. 1873, would create the

Biomedical Advanced Research and Development Agency (BARDA). In addition to

the FOI exemption, minutes, memos and such " shall not be subject to judicial

review " unless the Secretary decides there is no national security threat.

Ironically, in June this same Senate passed a bi-partisan measure (S. 1181)

by unanimous consent that would " bring increased sunshine to the federal

legislative process, " according to co-sponsor Sen. Pat Leahy (D-VT). It

would require bills with FOIA exemptions to state them " explicitly " in the

bill text; the bill languishes in the House Committee on Government Reform.

The National Vaccine Information Center calls BARDA " a drug company

stockholder's dream and a consumer's worst nightmare. "

The long bill title summarizes BARDA's purpose: " A bill to prepare and

strengthen the biodefenses of the United States against deliberate,

accidental, and natural outbreaks of illness, and for other purposes. " A

" natural " outbreak of illness would include a pandemic. The bill is a boon

for pharmaceutical companies, because BARDA would manage the federal

" government's anti-bioterrorism research and encourage private companies to

bring more drugs and vaccines to market quicker. "

With a FOIA exemption, the agency -- and the companies receiving tax money

-- would be exempt from judicial or public oversight. The bill also exempts

the agency from " rules designed to ensure efficiency and protect against

waste and fraud, " suggesting there would be little Congressional oversight

as well. It doesn't stop there: the companies that would be funded would

have a blanket exemption from liability lawsuits.

Bill Sponsors

So who are these Senators, who wish to hand out money with little or no

strings attached? In addition to Burr, chair of the Senate Bioterrorism and

Public Health Preparedness Subcommittee, there are five co-sponsors of the

89-page bill: Sen. (R-TN), Sen. Dole (R-NC), Sen. Enzi (R-WY),

Sen. Frist (R-TN) and Sen. Gregg (R-NH). As a group, they accepted almost $3

million in contributions from the health sector in the last election cycle;

more than one-third of this went to Burr.

Earlier this month, the Seattle Times called on Congress to " scrutinize " the

bill, nothing that not even Homeland Security or the CIA have the " luxury "

of FOI exemption. The Roanoke (VA) Times calls, instead, for " a vaccine

against official secrecy, " noting that bill sponsors " apparently could not

resist the penchant too prevalent among Washington leaders today for secrecy

and capitulation to corporate donors at the expense of civil protections. "

FOIA

FOIA was a hard-fought battle to shine the light of day on backroom

government practices; it spawned similar legislation in all 50 states. It,

along with other measures like the Federal Advisory Committee Act (FACA), is

an " open government " measure designed to provide citizen and media access to

government documents and actions.

President signed the FOIA on 4 July 1966, one day before a

pocket-veto would have killed the bill. In 1996, the Society of Professional

Journalists wrote:

[T]he FOIA has compelled federal agencies to yield millions of documents

relating to government operations and performance. Every week, a news

organization, scholar or public-interest group somewhere reports information

of significance to public health or safety or good governance — based on

material gleaned from FOIA requests.

Still, the FOIA has been something of a regulatory pariah over its 30-year

history. Congressional oversight and agency reporting have been superficial

and episodic at best. Funding has been inadequate. Compliance has ranged

from enthusiastic implementation to sullen resistance to active

interference.

The first national Sunshine Week (your right to know) was launched in 2005.

Bioterrorism and the use of Fear in Public Health, s & Obrien, LSU

Law Center; Frist Urges Germ Spies (Atlanta Journal-Constitution) ; BARDA

bill text (pdf)

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills & docid=f\

:s1873is.txt.pdf