[NVIC] Bush Wants Free Ride for Drug Companies

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Vienna, Virginia http://www.nvic.org

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" Protecting the health and informed consent rights of children since 1982. "

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BL Fisher Note:

In 1982, there were four drug companies manufacturing vaccines: Wyeth,

Lederle, Connaught and Merck. Today, after mergers and acquisitions in the

pharmaceutical industry during the past two decades and protection from most

liability for vaccines injuries under the National Childhood Vaccine Injury

Act of 1986, there are many more drug companies in the multi-billion dollar

U.S. vaccine business including Aventis, GlaxoKline, VaxGen, and

Chiron. It is a myth that vaccines are not profitable for drug companies. In

the U.S. the vaccine business can't help but be profitable when most

vaccines are mandated and liability has been severely limited and wiill soon

be totally nonexistent.

http://news./s/ap/20051101/ap_on_go_pr_wh/bird_flu_liability_2

News

Bush Seeks to Protect Vaccine Makers

By KEVIN FREKING, Associated Press Writer

Tue Nov 1, 5:32 PM ET

WASHINGTON - President Bush said Tuesday that granting vaccine

manufacturers protection from civil lawsuits would go a long way to spur the

development of medicine needed to fight a potential pandemic.

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" In the past three decades, the number of vaccine manufacturers in America

has plummeted, as the industry has been flooded with lawsuits, " Bush said.

" Today, there is only one manufacturer in the United States that can produce

influenza vaccine. "

Not everyone agrees with Bush's reasoning. Officials have pointed out what

they consider more significant reasons for the small number of flu vaccine

producers worldwide.

Bush proposed the protection on Tuesday as he outlined a national strategy

for dealing with a possible flu pandemic, including billions of dollars to

buy and stockpile vaccines.

Bush made a similar lawsuit indemnification argument last year when a

shortage of flu vaccine became an issue in the presidential election.

British regulators had suspended the license of a company that makes vaccine

for the U.S. market and, as a result, the U.S. received about half of the

supply that officials had anticipated.

Fauci, the infectious disease chief at the National Institutes

of Health, told The Associated Press last year that more significant issues

are the low-profit margin vaccines provide, unpredictable demand and the

complexity of the manufacturing process.

The trade association for trial lawyers cited Fauci's comments on Tuesday

when criticizing the president's proposal as a " huge giveaway to drug

companies that are making record-breaking profits. "

" If he was really interested in protecting the public, he would not call for

the elimination of these important legal protections, " said Mather,

communications director for the Association of Trial Lawyers of America.

" And his claims that lawsuits are keeping these companies out of the

business is just plain wrong. "

Several bills have been introduced in Congress that are designed to enhance

the ability of the United States to thwart or diminish a pandemic. Two weeks

ago, the Senate's health committee approved a bill that said the

" manufacturer, distributor or administrator " of a pandemic product shall be

immune from lawsuits caused by the dispensing of that product.

The legislation gives the secretary for the Health and Human Services

Department authority to designate which products are necessary for fighting

an epidemic or pandemic.

The Senate has not yet approved the bill, but it is expected to begin debate

on it within the next two weeks.

Republicans on the House Energy and Commerce Committee have also said

they're interested in taking up legislation that would improve pandemic

preparedness, and No. 2 on their list of priorities was providing liability

protection to increase vaccine manufacturing and distribution capacity.

The federal government administers a compensation program for people injured

by certain vaccines, such as those for tetanus, measles and polio. Just last

year, Congress added the annual flu shot to the program. People who believe

they have been injured by a covered vaccine can file a claim against the

Health and Human Services Department in the U.S. Court of Federal Claims. If

found eligible, they can recover compensation for medical expenses.

Often, awards exceed $1 million, and a fact sheet about the program on the

Justice Department Web site says that " costly litigation against drug

manufacturers and health professionals who administer vaccines has virtually

ceased. "

The trade group representing drug makers applauded Bush's call for liability

protection. No medicine is risk-free, and it's certain that a pandemic flu

vaccine would be rushed to production once shown to be effective.

" Companies should not be forced to balance the need of finding an effective

vaccine for this potentially devastating pandemic against the certain

knowledge that trial lawyers will pursue claims exploiting the inherent

risks of vaccine development, " said Tauzin, president and CEO of The

Pharmaceutical Research and Manufacturers of America.

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