UPDATE ON PHARMACEUTICAL COMPANY IMMUNITY LEGISLATION
(2/16/06)
To Take Action Click Here
Congressional leaders announced (2/15/06) the introduction of legislation to repeal the S. 2291)
introduced by Senators Kennedy, Dodd, Harkin and Bingaman is described
as "[a] bill to provide for the establishment of a biodefense injury
compensation program and to provide indemnification for producers of
countermeasures." For the news story here.
Senator Kennedy and others issued a letter to Sen. Frist and Hastert
protesting the way the existing legislation was enacted (which they
described as a "travesty of the legislative process") and called for
more equitable legislation that provides an adequate compensation
program for victims of vaccine injury. You can obtain a pdf of
Sen. Kennedy's letter by clicking here.
A-CHAMP
will analyze S. 2291 to determine if it is sufficient to address the
needs of those injured by vaccines and whether it sufficiently guards
the safety of vaccines. But we know that the newly proposed legislation
is a welcome effort to correct the injustices contained in the the
"Public Readiness and Emergency Preparedness Act" and to conduct an
open and fair public debate on vaccine policy.
The
action in Congress came on the heels of an announcement by Health and
Human Services Secretary that an "emergency" would be declared to give
vaccine makers liability protection for clinical trials of the
experimental flu vaccine. For the story "here.
Congress Passes Unprecedented Legislation
Giving Immunity to Drug Companies
Legislative Process Abused by Exercise of
Political Muscle and Parliamentary Trick
Click
here to
Take Action and send a message to repeal the
"Public Readiness and Emergency Preparedness Act"
– far-reaching and unprecedented legislation giving liability
protection to vaccine makers and preempting state vaccine safety
legislation for pandemic countermeasures. For a brief and excellent
audio report of how the Congressional Leadership manipulated the Rules
and attached their legislation to an unrelated Defense spending bill to
get this legislation enacted click
here.
This
legislation, passed by the House of Representatives in the early
morning hours of December 19, 2005 was muscled into the Department of
Defense Appropriations, H.R. 2863, bill by Senator Frist and House
Speaker Hastert despite assurances made to Representatives that this
provision would not be attached to the Defense spending bill. Rep. Dan
Burton (R-IN) spoke in opposition to the provision - you can read his remarks by clicking here
– as did a number of Democrats, including House Appropriations
Committee ranking Democrat David Obey of Wisconsin. "The conference
committee ended its work with the understanding, both verbal and in
writing, that there would be no, I repeat, no legislative liability
protection language inserted in this bill," Obey said on the House
floor.
"That
legislation was unilaterally and arrogantly inserted into the bill
after the conference was over," Obey said, adding that it was "a
blatantly abusive power play by two of the most powerful men in
Congress."
When
the immunity legislation was considered by the Senate it was first
rejected along with the entire Defense Appropriations bill when a vote
to close debate on the bill was defeated. Opponents of the bill
threatened a filibuster with opponents of controversial provisions on
the bill criticizing the abuse of Senate Rules that resulted in
inclusion of the bill provisions that were unrelated to the Defense
spending provisions. This procedural roadblock precipitated
negotiations between the Democrat and Republican leadership that
resulted removal of a controversial provision that would have allowed
drilling for oil in the Alaska National Wildlife Refuge ("ANWR") – a
controversial provision vehemently opposed by environmentalists that
had been the subject of legislative battles for two decades. In a
legislative compromise ANWR was stripped out of the bill but the
controversial drug company immunity provisions remained. The Senate
voted for this newly amended version of the Defense Appropriations Bill
in a 48-45 vote. The Senate then passed the amended bill – including
the pharmaceutical immunity provisions in a 93 to 0 vote. Little
opposition to the immunity provision was voiced prior to the final
vote.
Back
in the House of Representatives the provisions were passed by unanimous
consent after statements in opposition to the Bill were made and then
withdrawn by Rep. Obey.
Senator
Edward Kennedy (D-MA) criticized the legislation as far broader than
anything discussed in negotiations. Senator Kennedy called the
legislation a "a basic blank check for the industry, not only on
pandemic flu, but just about any other kind of, quote, epidemic that
anyone can think of." Other legislators felt that the legislation would
do more to undermine the vaccine program by raising concerns over the
safety of vaccines rushed to market without proper scrutiny, just like
the recent experience with the smallpox vaccine. "The nightmare
scenario I'm concerned about is you start having doctors and nurses
refusing the vaccine, and then if that gets in the press, then nobody
will take their shots," said Rep. Dave Weldon (R-FL).
A-CHAMP
and Eagle Forum ran a series of full page advertisements in Washington
D.C. newspapers during the week when the legislation was debated in
Congress. You can view a pdf of the advertisement
here and A-CHAMP's and other children's safety organizations' letter to President Bush
here.
Here is a partial list of the reasons why A-CHAMP objects to provisions
contained in the "Public Readiness and Emergency Preparedness Act":
1) The legislation allows use of Thimerosal in vaccines:
If the Secretary of Health and Human Services designates that a vaccine
is a "covered countermeasure" Thimerosal (a mercury containing
preservative) can be used in the vaccine, even if a state has
enacting legislation banning or limiting the use of Thimerosal. Any
state legislation covering vaccines would be rendered ineffective and
Federal law would preempt all state provisions. This applies to any
state provision governing vaccines, not just those provisions
pertaining to Thimerosal. Click
here to view a pdf file that shows the text of the provision in the "Public Readiness and Emergency Preparedness Act"preempting State law for a "covered countermeasure."
2) The legislation provides immunity for ALL Drugs and Vaccines:
The language contained in the legislation applies to any drug, vaccine,
or biological product that the Secretary of Health and Human Services
deems a “covered countermeasure.” This list could include any
commercial drug like Tylenol and is not limited in any way to drugs or
vaccines meant to treat a pandemic like avian flu. The
far-reaching nature of the bill was misrepresented in Congress and in
much of the media, where the legislation was presented as primarily
concerned with preparations to combat the avian flu. Since the HHS
Secretary has described everything from obesity to diabetes to heart
disease as epidemics, under the term of this legislation many drugs and
vaccines can be covered, whether or not the relate to dangerous
pandemics or bioterrorism. There is a serious potential for abuse of
this provision by an Executive branch of government known to be
friendly to the pharmaceutical industry.
3) Under the legislation immunity can be granted to drug companies at ANY Time:
The immunity language depends on the HHS Secretary declaring that a
health condition causes a public health emergency or that some health
condition could become an emergency at some point in the future.
There is nothing in the language of this legislation that requires an
actual pandemic or health emergency to exist before the Secretary
declares an emergency that triggers the immunity provisions. Thus
the Secretary has broad authority to declare an emergency triggering
drug company immunity at any time for almost any reason.
4) The
legislation gives drug companies immunity for harm caused by their misconduct:
The immunity conferred on drug and vaccine manufacturers applies no
matter what the drug company did wrong. Even if a drug company
operates a dirty facility in which a batch of vaccines is contaminated,
and that vaccine kills thousands of Americans, the drug company is
immune from liability.
5) The
legislation gives drug companies immunity for all acts short of assault or murder:
The legislation's language explicitly protects drug companies who act
recklessly or who are grossly negligent. An injured person's claim can
go forward only in the case where a drug company acted with such
willful misconduct as to constitute criminal assault or murder.
Anything less than criminal conduct is protected. This language
provides the highest standard of proof known to civil law and is
unprecedented.
6) Immunity for Murder unless the Secretary or the Attorney General Say Otherwise:
Even if a drug company has acted with “willful misconduct” as defined
by this language, the drug company is still immune from accountability
unless the Secretary or the Attorney General initiates an enforcement
action against the drug company and that action is pending at the time
a claim is filed or the action resulted in some form of punishment. So
even if a drug company knowingly kills thousands of people, if no
official enforcement action is taken, that company is still
immune.
7.
Vaccine Safety is Compromised by this bill:
The
express purpose of this legislation is to encourage rapid production of
sufficient doses of vaccine to inoculate most of the United States
population. The vaccine manufacturers used blackmail to push the
legislation by stating they would refuse to produce new vaccines, the
avian flu vaccine for example, unless the legislation was enacted. The
legislation would permit new vaccines to be rushed to market despite
risks that would otherwise cause a legally vulnerable manufacturer to
exercise caution. The tort system in America has historically been
designed to discourage the use of risky products. This legislation
changes all that. There exist substances proposed as vaccine
ingredients that have been insufficiently tested and pose potential
health risks. One such substance, a vaccine adjuvant called "MF59" is
an oil based substance used to enhance the body's immune reaction to a
vaccine. Our public health authorities wish to use MF59 in vaccines in
order to enhance production capabilities. In a recent broadcast of
NBC's Face the Nation Julie Gerberding, head of the Centers for Disease
Control, told Tim Russert that "hamburger helper", public health's
nickname for MF59, would be used to extend the supply of
vaccines. What Dr. Gerberding did not tell the public is MF59 is
reported to have been used in an experimental anthrax vaccine given to
members of the military causing a variety of autoimmune illnesses such
as lupus and arthritis, and resulting in the death of a number of
victims. For more on MF59 read the recent book
Vaccine A, by reporter Gary Matsumoto.
Take Action to Tell Your Senator To Repeal the "Public Readiness and Emergency Preparedness Act"!
