Some night time reading:
Zeus Note: This legislation was passed just before Christmas. Below are a collection of related articles. Some of the links that no longer work have been taken out.
From: Emma Holister
Senate Moves Towards Forced Vaccinations, Vaccine Damage Immunity for Drug Companies
Associated Press | December 2, 2005
By ANDREW BRIDGES
RELATED:
CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES
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.
____________________________________
Thanks to Sheri Nakken, R.N., MA, Classical Homeopath, for sending the articles below:-
http://www.nccn.net
IMMUNITY FOR THE DRUG INDUSTRY 22/12/05 - Written by the Democratic Health, Education, Labor, and Pensions Staff, addressing scandalous language added in once again by Senator Frist, in a must pass DoD appropriations bill:
In the middle of the night, Republican leaders attached sweeping,
never-before-seen immunity for drug companies into the Department of
Defense Appropriations Conference Report. The language constitutes an
unprecedented pharmaceutical industry wish-list of liability protections
that go way beyond avian flu preparedness and that will allow the industry
to injure or kill Americans with contaminated drugs and vaccines and never
be held accountable. This language is broader than any House or Senate
bill and has never been considered by any committee or passed by either
body. The language in fact, even expressly immunizes pharmaceutical
company recklessness.
The language:
Applies to a wide range of drugs, vaccines, and other products. The
proposal provides that any "drug, biological product or device that is used
to mitigate, prevent, treat, or cure a pandemic or epidemic or limit the
harm such pandemic or epidemic might otherwise cause." may be covered and
given immunity. The proposal does not, in any way, limit its application
only to new drugs or vaccines used in a pandemic context. The scope of the
proposal is so broad that it could include drugs like Tylenol, Advil or
Vioxx.
Allows the Secretary to declare an emergency under ANY circumstance. The
immunity for drug companies is triggered upon a declaration by the
Secretary of Health and Human Services (HHS). The language is so broad
that it allows the Secretary to make a declaration at any time, for almost
any reason, and for any period of time he or she so chooses. The Secretary
may make a declaration pursuant to this section if a disease or health
condition is a public health emergency or "there is a credible risk that
the disease, condition, or threat may in the future constitute such an
emergency." [emphasis added.] There will always be a future risk of a
health condition becoming an emergency, but that future risk alone should
not be enough to justify total immunity for the pharmaceutical industry.
This declaration is not subject to appeal, or to any independent judicial
review.
Provides for total preemption of state law during the declaration. The
language also preempts all state laws, requirements, or state tort law that
is different from or in conflict with the federal rule.
Immunizes drug companies for reckless and grossly negligent conduct. The
only exception to the grant of wholesale immunity is in the case of
"willful misconduct." However, willful misconduct is defined as evidence
that the drug company had actual knowledge that their product would injure
or kill someone. This requirement means that only conduct that would also
constitute assault, battery or murder would be sufficient to find "willful
misconduct." The language explicitly protects recklessness by stating, "a
standard for liability that is more stringent that a standard of negligence
in any form or recklessness." That is language never before seen in any
proposed bill.
Immunizes criminal conduct when the Secretary or the Attorney General fails
to act. 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.
Erects insurmountable barriers such that Americans will never be able to
hold a drug company accountable. Under the language, a person who has been
injured by a dangerous drug or vaccine must prove "by clear and convincing
evidence willful misconduct" on the part of each and every defendant drug
company. This standard of proof is so high, and rarely used in civil
proceedings, that the injured individual will never be able to hold a drug
company accountable.
Includes severe restrictions even if a claim is allowed. In the unlikely
event that a claim is allowed to go forward because a court has found
sufficient evidence that a drug company intentionally and willfully injured
or killed a person, the following restrictions would still apply:
* The complaint must be accompanied by physician's affidavit by a doctor
who did not treat the person that the person is suffering from an effect of
the covered countermeasure;
* The injured individual must provide their medical records that show that
the injury was caused by that countermeasure;
* An exclusive federal cause of action, barring individuals from filing a
claim in their own state court under state law;
* The elimination of the collateral source rule such that any damage award
received by the injured person would be reduced by any other payment
received by the individual, such as health insurance or disability benefits;
Includes provisions of the so-called "Lawsuit Abuse Reduction Act" (LARA).
Proponents have even dumped into this proposal provisions of LARA, a bill
which has twice passed the House but has never been considered in the
Senate. Among other things, the proposal would amend the Federal Rules of
Civil Procedure without following the normal rule-making processes.
Establishes a "compensation" fund under the sole direction of the
Secretary. The language establishes a fund similar to the smallpox
compensation fund. However, the fund is operated under regulations
established by the Secretary alone, includes caps on compensation, and is
inoperable until Congress appropriates a sufficient amount of money for the
fund to operate.
_________________________________________
"Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's
pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines
against human papilloma virus, a sexually transmitted disease that is a
major cause of cervical cancer, could be big sellers for Merck & Co. and
Glaxo who are each developing one. "
http://www.thnt.com/apps/pbcs.dll/article?.../512110337/1003
Drug makers seek protection
Home News Tribune Online 12/11/05
THERESA AGOVINO
THE ASSOCIATED PRESS
NEW YORK - Large pharmaceutical companies are approaching development of
vaccines and drugs for potential pandemics with trepidation, even as fears
abound of a bird flu outbreak and doctors lament a shortage of treatment
options.
Drug makers are especially afraid of lawsuits stemming from vaccines which,
unlike drugs, are given to healthy people, making any harm they cause an
even bigger legal risk.
Proposals in Congress would exempt companies that manufacture vaccines and
drugs for pandemics from lawsuits. Senator Bill Frist, R-Tenn., is trying
to put a rider on a spending bill that would immunize drug makers and
another freestanding bill introduced by Senator Richard Burr, R-N.C., seeks
to accomplish the same goal.
That's a necessary safeguard to promote interest in developing those
medicines, drug makers say.
"We won't do it without indemnification," said Len Lavenda, a spokesman for
Sanofi Pasteur, the vaccine arm of Sanofi-Aventis SA.
But some insist immunizing drug companies won't be enough to spark interest
in a field fraught with an uncertain pricing structure. Unlike drugs for
conditions such as cholesterol and high blood pressure, which have
guaranteed markets, medicines for pandemics will only be used sporadically,
if at all.
The government adds to the pricing pressure. The Centers for Disease
Control and Prevention buys 55 percent of the recommended childhood
vaccines and pays substantially less than the private sector, so some
experts suspect payments for pandemic treatments will be less than generous.
When anthrax fears surfaced after the Sept. 11 attacks, the U.S. government
threatened to break the patent covering Cipro, an antibiotic made by Bayer
AG. And Roche Holding Ltd. has already been under tremendous pressure to
lower the cost of its Tamiflu, which is believed to be effective against
bird flu, and give others permission to make it.
"Companies are worried about low prices," said Frank Sloan, professor of
health policy, law and management at Duke University.
"They are worried they won't recoup their research and development costs,"
he said. "That is the real problem."
In a statement, Senator Edward Kennedy, D-Mass., called the attempts to
indemnify companies "a sweetheart deal for the drug industry."
A spokesman for Burr said his bill contains provisions to compensate people
hurt from treatments through government funds and that companies will only
be indemnified when the product is used in a pandemic, not for a general
medical problem.
The drug industry insists such moves are crucial. In a pandemic, a vaccine
may be approved without the same level of testing that would be normally
required and given to virtually all Americans.
"This is 300 million plaintiffs you are talking about," said John Clerici,
a lawyer who represents Sanofi and other companies. "If they get anything,
they'll blame it on the vaccine."
Sheltering drug companies from lawsuits isn't without precedent. Acambis
PLC was protected to make an Anthrax vaccine and the manufacturers of swine
flu vaccines were given the same treatment back in the 1970s.
Individuals seriously harmed by vaccines the U.S. government recommends for
children are paid through a federal pool funded by a tax on inoculations.
But Lavenda said lawyers are seeking ways to collect damages from companies
instead of the government fund.
Chris Viehbacher, president of GlaxoSmithKline PLC's U.S. pharmaceuticals
business, estimates the industry has spent $200 million preparing itself
for lawsuits over a vaccine preservative in children' s vaccines.
Lavenda said the issue of immunity from lawsuits must be cleared before
other negotiations can begin on issues such as price.
Lobbyists and pharmaceutical executives said the main force pushing for
indemnity is not the drug industry, but the Biotechnology Industry
Organization, a trade group. BIO declined comment, but lobbyists and
analysts suggested its members are far more interested in pandemic
medicines than drug companies.
"Biotech companies are more amenable to working in new areas. They are
startups," said Christopher Milne, assistant director at the Tufts Center
for the Study of Drug Development. "Big pharmaceutical companies are
resistant to getting heavily involved where the government is paying. They
remember the Cipro incident."
Generex Biotechnology Corp. recently hired a lobbying firm to help it get
government contracts to develop its bird flu vaccine.
Anna Gluskin, Generex's chairwoman, CEO and president, said she isn't
worried about lawsuits because the company's vaccine is made from synthetic
proteins, which she maintains is a safer manufacturing process.
Some pharmaceutical companies have chosen to develop a vaccine for bird
flu. Sanofi Pasteur has a government contract to produce 8,000 doses of an
experimental vaccine, but it has received indemnity from lawsuits. Glaxo
said it will start a small trial in Europe during the first quarter of next
year, and discussions with regulators haven't progressed enough to have
included the indemnity issue.
Viehbacher said any company which successfully creates a vaccine would have
leverage over the government. Vaccine production is complicated, so
breaking a patent wouldn't guarantee supply, he said.
Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's
pneumococcal vaccine, revenues total over $1 billion. Analysts say vaccines
against human papilloma virus, a sexually transmitted disease that is a
major cause of cervical cancer, could be big sellers for Merck & Co. and
Glaxo who are each developing one.
_______________________________________
U.S. Senators with up to $13.4 million in pharmaceutical holdings increased the value of their stock portfolios last night when they approved an amendment to the defense appropriations bill that immunizes drug makers from accountability to the public when they sell dangerous drugs and other products, according to the Foundation for Taxpayer and Consumer Rights (FTCR).
___________________________________________
http://www.whitehouse.gov/news/releases/20...0051222-10.html
President Applauds Congress for Passing Defense Appropriations Bill
I applaud the Congress for passing legislation to fund our troops who are
fighting the war on terror in Iraq, Afghanistan, and elsewhere. This
funding will help us continue to hunt down the terrorists, pursue our
strategy for victory in Iraq, and make America more secure. I look forward
to signing the bill into law.
What the president does not mention in the 'making of America more secure'
- is that in the bill, Senator Frist slipped language into the bill
indemnifying manufacturers from their products (drugs/vaccines, et. al)
that can harm, disable and/or kill the American people. The arctic drilling
was widely focussed on, and that amendment was pulled from the bill. The
environment in Alaska is now safe - Americans in the US however, are now
not. What the president also fails to mention is that he was the #1
recipient of contribution funds for the 2004 election, bringing in over
$1,000,000.00 from PHARMA.
http://www.secretwebsites.com/say_no_to_drugs.htm - For those that believe
I'm slamming Republicans, I am not - it just so happens those mainly
responsible are Republicans - but, there are a few democrats as well.
Again, here are the 38 senators that voted this bill in, with a conflict of
interest with ties to the pharmaceuticals (stock holdings):
Allen (R-Va.), Bayh (D-Ind.), Bingaman (D-N.M.), Bond (R-Mo.), Boxer
(D-Calif.), Brownback (R-Kan.), Burns (R-Mont.), Carper (D-Del.), Coburn
(R-Okla.), Cochran (R-Miss.), Conrad (D-N.D.), Crapo (R-Idaho), Dayton
(D-Minn.), DeWine (R-Ohio), Dole (R-N.C.), Ensign (R-Nev.), Feinstein
(D-Calif.), Frist (R-Tenn.), Hatch (R-Utah), Hutchison (R-Texas), Inhofe
(R-Okla.), Isakson (R-Ga.), Kerry (D-Mass.), Kyl (R-Ariz.), Landrieu
(D-La.), Lautenberg (D-N.J.), Levin (D-Mich.), Lieberman (D-Conn.), Lott
(R-Miss.), Reed (D-R.I.), Reid (D-Nev.), Roberts (R-Kan.), Stevens
(R-Alaska), Sununu (R-N.H.), Talent (R-Mo.), Vitter (R-La.), Voinovich
(R-Ohio) and Warner (R-Va.).
If you notice that your state/senator is listed above, congratulations -
you just noticed that your Senator just screwed you over (don't expect a
dinner - and remember this on election day). If you think that PHARMA does
not run this country, think again. PHARMA has just proven that they can
buy and even own Congress and the President. With all the hype on
"protecing america against the war on terrorism" - today, America has just
been taken hostage by its own government.
Read the below statemement from Dem. David Obey (WI) - it is long, but, it
is very much worth the read. There are few exceptions to those in power who
I believe are trying to do the right thing for their constituents and
America - this gentleman below is one of them.
House Committee On Appropriations, Democratic Staff
David R. Obey (WI-07), Ranking Member
For Immediate Release
Contact: Kirstin Brost
December 22, 2005
202-593-1310
Obey Statement on Defense Appropriations Correction Bill
A Shameful End to a Shameful Congress
WASHINGON -Dave Obey (D-WI), Ranking Member of the House Appropriations
Committee, made the following statement this afternoon on the bill
stripping the provision to allow drilling in the Arctic National Wildlife
Refuge (ANWR) from the Defense Appropriations Conference report:
"Mr. Speaker, reserving the right to object:
"More than a year ago, when Mr. Lewis was elected Chairman of the
Appropriations Committee, he came to me and asked if we could have an
understanding that we would express our substantive differences but still
cooperate in moving bills forward in an orderly way once those differences
had been expressed. We did that.
"Time and time again, the Minority was denied the opportunity to offer
different sets of priorities, priorities that did not offer huge tax cuts
for those who have the most in society, paid for with cuts in education,
health care, and worker protection for those who have the least. Despite
the fact that the rules of the House were used to block our efforts to
obtain on-the-record votes on a number of our alternatives, Democrats
continued to cooperate procedurally, even as we made clear our
differences on policy.
"The Republican Majority wanted to finish all of these bills by the end of
the fiscal year, and we did not procedurally obstruct them because while we
differed strongly with the values that lie behind their budget priorities,
we respected the fact that they are in the Majority and we respect and
revere this institution. But because of internal divisions between the
Majority party - divisions within the House GOP caucus and divisions
between House and Senate Republicans - the fiscal year ended with the
Labor-HHS bill and the Defense appropriations bill that represent 67
percent of the discretionary spending in our budget bill still being hung
up in the legislative process.
"Now in the closing days of this Congress, the Republican Leadership has
decided to use the must-pass Defense appropriations bill to force down the
throats of the American people a number of wholly unrelated gifts to
special interests. They decided to hold funds for our troops hostage in
order to force Congress into removing protections against oil drilling in
ANWR. To make room for their tax giveaways, they even imposed a second
round of cuts to education, health, worker protection, and even imposing a
$4 billion cut in military spending.
"Senate action yesterday has corrected one provision inserted in the bill
by abuse of power - the strong-arm attempt at drilling in ANWR - and for
that I mildly applaud the Senate. I led the opposition to ANWR's inclusion
in the Conference and I am happy that the Congress was not blackmailed into
accepting it.
"But frankly Mr. Speaker, continuing under my reservation, ANWR was not the
biggest problem with the Conference report. The biggest problem is that it
shortchanges our economic future by refusing to make adequate investments
in education and it cruelly neglects to strengthen support for programs
that help provide critical health care services to people who desperately
need them. But we have lost that fight. This Congress has made the
decision to cut critical health, education, worker protection, and social
service funding by $3 billion below last year's level. What I find to be
so gutless about Congress' performance on this bill is that those cuts
could not pass the Senate on a roll call vote, so the Majority party had to
arrange for their Senators to duck this vote and hide from accountability
by arranging for the bill to be passed without a roll call vote. That
means the Majority party has denied critical help to families most in need
of help, but has not had the courage to forthrightly defend their votes to
the people affected in the public arena. This bill makes that problem $1.4
billion worse for those programs and because of the across-the-board cut,
it makes other ill-advised cuts in critical funding for the FBI, local law
enforcement, and it even cuts an additional $4 billion out of the defense
bill. If I could do anything to change that, I would. But it is clear
that the die is cast.
"Continuing under my reservation Mr. Speaker, there is a second outrageous
problem with this bill. The Majority has turned the proposal to prepare
for a flu pandemic into a giveaway to the pharmaceutical industry.
"When the President requested $7 billion to begin a much belated crash
program to develop a new generation of vaccines and antiviral drugs to
combat a potential flu pandemic, the Republican Majority responded by
cutting it in half. When I asked Senator Stevens in Conference why we
shouldn't fund the rest of the Administration's request so that it was
clear that the government had a long-term commitment to the development of
needed vaccines and antivirals, he responded that because liability
protection language for manufacturers was not being adopted, long-range
funding should be withheld. The Conference Committee ended its work with
an understanding, both verbal and in writing, that there would be no -- I
repeat no -- legislative liability protection language inserted in this
bill. And because the Majority told us it did not want any compensation
program for victims to come out of the discretionary portion of the budget,
no funding was provided for that either. But after the Conference was
finished at 6pm, Senator Frist marched over to the House side of the
Capitol about four hours later and insisted that 40 pages of legislation -
which I have in my hand - 40 pages of legislation that had never been seen
by Conferees be attached to the bill. The Speaker joined him in that
insistence so that, without a vote of the Conferees, that legislation was
unilaterally and arrogantly inserted into the bill after the Conference was
over in a blatantly abusive power play by two of the most powerful men in
Congress. We then discovered that this language provided all sorts of
insulation for pharmaceutical companies and that this insulation applied
not just to drugs developed to deal with the flu, but in fact applied to a
far broader range of products.
"In essence, the provisions allow the Secretary of HHS to issue a
declaration that has the effect of almost completely prohibiting lawsuits
in state or federal courts by persons whose health was injured against
manufacturers and various others for compensation for injuries caused by
the use of "covered countermeasures." That determination would bar
lawsuits against a wide range of "covered persons" involved with the
countermeasures-including manufacturers and their suppliers, distributors,
state and local governments and their employees involved with use of the
countermeasures, medical personnel prescribing and administering the
countermeasures, and so forth. This is very broad power indeed to ban
lawsuits. Unlike the language requested by the Administration, the
Division E language is not limited to products to combat a flu pandemic.
Rather, it applies to any drug, vaccine, medical device or other products
useful in dealing with anything the Secretary considers to constitute a
public health emergency or that could constitute an emergency in the future.
"Although a rationale often offered for lawsuit protection is that it is
needed to encourage manufacturers to develop and produce new treatments,
the protections of Division E are not limited to new or experimental
products. Rather, nothing in the language would prevent the Secretary from
providing protection against lawsuits to drugs that have been on the market
for decades.
"Further, the language explicitly prohibits any judicial review, in either
federal or state court, of the Secretary's decisions to grant immunity from
lawsuits. If anyone believes that the power is being exercised too
broadly, or even in violation of the law, they apparently would have no
remedy other than asking the Secretary to change his mind or asking
Congress to amend the law.
"Although proponents point to provisions of this language that make an
exception and allow lawsuits in cases of willful misconduct, that exception
is so narrowly drawn as to be almost meaningless. First, the provision
defines "willful misconduct" as acts taken "intentionally to achieve a
wrongful purpose", knowing there is no legal or factual justification, and
in disregard of known or obvious great risk. Basically, Mr. Speaker, the
only conduct that would permit a lawsuit under this definition is probably
conduct so egregious as to be criminal in nature.
"However, even this highly restrictive definition of "willful misconduct"
doesn't seem to have been enough restriction on lawsuits to satisfy the
authors of Division E. They added yet another provision that allows the
Secretary of HHS to promulgate regulations further narrowing the scope of
actions that could give rise to a right to sue. Then, there's yet another
provision that says if the conduct in question is regulated under the Food
and Drug Act or Public Health Service Act, a lawsuit for willful misconduct
can be brought only if the federal government has taken enforcement action
against that conduct. Finally, the language makes various changes to the
normal rules of civil procedure to add further obstacles and difficulties
in front of a potential plaintiff. In short, as a practical matter there
is virtually no right for anyone to sue about anything covered by a
Secretarial determination under this language.
"In summary, the Administration asked for some very broad liability
protections for manufacturers and others involved with countermeasures
against pandemic flu - and the Administration's proposal was widely
criticized as going too far. With Division E of the Defense appropriations
Conference report, Congress would be providing even broader protection,
potentially covering a wide range of drugs, vaccines and devices far beyond
what is needed to deal with the flu.
"Further, this denial of the right to sue is more sweeping than provided in
the case of childhood vaccines, or in the case of smallpox vaccine. In the
smallpox case, manufacturers are protected by basically substituting the
federal government as defendant-with the scope of potential lawsuits
against the federal government narrowed but not eliminated.
"Now Mr. Speaker, I recognize that some sort of liability protection or
indemnification that would be necessary and appropriate to encourage
development and manufacture of some measures to deal with pandemic flu and
I would support such reasonable language, language that has been reviewed
by a Committee that knows what it is doing in a process that allows for
public comments. But there are real doubts as to whether it needs to be
this broad. Its worth noting that Sanofi Pasteur, our only domestic flu
vaccine manufacturer, has already signed contracts with the federal
government to make avian flu vaccine and has already delivered some lots,
rather than refusing to proceed until legislation like this is enacted.
Similarly, Roche has been supplying Tamiflu for the national stockpile and
actively seeking contracts to supply more.
"The result of this legislative action was a provision in the pending bill
that prevents anyone who is a victim of a faulty vaccine from being able to
obtain compensation in the courts. It says that if you become seriously
ill because of mistakes in the manufacturing, that you lose your right to
sue for compensation, but you can seek compensation from the government.
But guess what -- the problem is that no money was provided for that fund.
So anyone who gets sick would have to lobby Congress to put money in the
money in the fund before they can collect. Thus, people injured lose their
right to sue, but are not guaranteed any alternative means of covering
their medical bills, lost earnings and other costs.
"Mr. Speaker, the Committee system was created years ago to ensure that to
protect the public interest, legislation would be carefully reviewed before
it was placed before the body for consideration. But that protection was
arbitrarily by-passed by the Leadership in both Houses.
"This is the second time that this Congress has supinely done the bidding
of the pharmaceutical industry in the dead of night. The first time, a
vote was held open for three hours while the Republican Majority twisted
arms to create the complex and ridiculously confusing prescription drug
bill that our seniors are now so desperately trying to understand - a bill
that was ushered through this institution by over 600 lobbyists and that
protected companies by preventing the government from even attempting to
negotiate lower drug prices.
"If I thought that denying unanimous consent on this bill would force the
Majority to eliminate that language I would object. But, Mr. Speaker, it
has also been made quite clear to me that the Majority will not relent on
the language that insulates drug companies. So Mr. Speaker, I want it to
be clear that the action to insert this special interest language in the
bill is in my view a corruption of the legislative practices of the House.
When Congress returns in January, I intend to raise a question about the
privileges of the House that are highlighted by this action because it has
brought discredit to the House and should disturb every Member who serves
here. No Member of Congress, no matter how powerful, should be able to
unilaterally insist that provisions that were never discussed and never
debated in the Conference should be slipped in to that Conference report
without a vote of that same Conference.
"This is what happens when there are no checks and balances, when one party
controls the White House, the Senate, and the House and respects no limits
on its own use of power. We have been placed in the this position because
the House Republican Leadership has sent Members home for the Christmas
holidays with the message to the Senate that we would not be here even if
the Senate changed the legislation the House sent. That was irresponsible
and the country will pay the price. This institution will pay a price as
well, in terms of diminished respect from the people we were elected to
represent. Members on both sides know it and it is time to have a modicum
of respect for the way we do the people's business.
"This is a shameful and shabby way to the end the worst session of Congress
I've experienced in 36 years in Congress. I most reluctantly withdraw my
reservation because lodging an objection at this point would simply delay
the shameful inevitable."
forwarded by
Zeus Information Service
Alternative Views on Health
www.zeusinfoservice.com
