[NVIC] Another Bill to Immunize Big Pharma

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

#9119

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

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BL Fisher Note:

This bill, like S.3, is really Project Bioshield 2 - created to give more

money to the pharmaceutical industry to make experimental vaccines that

won't have to pass FDA standards and can be forced on citizens while drug

companies selling the vaccines will be immunized from liability for vaccine

injuries and deaths. For more information on Project Bioshield and S.3, go

to www.nvic.org

http://online.wsj.com/article_print/0,,SB111231124197694876,00.html

The Wall Street Journal

April 1, 2005

'Bioshield' Drug-Patent Plan Draws Fire

Generics Makers Fight Extending Exclusivity Protection to Areas Outside

Biodefense

By SARAH LUECK

Staff Reporter of THE WALL STREET JOURNAL

Less than a year after Congress provided the pharmaceuticals industry with

incentives to develop drugs for terrorism-related illnesses, a fight is

brewing over efforts to offer more goodies -- including the chance to extend

patent rights on medications that have nothing to do with homeland security.

Last year's legislation, signed by President Bush in July, provided $5.6

billion for the government to buy and stockpile medications to combat

bioterrorism agents such as anthrax and smallpox. Now some lawmakers,

convinced the measure didn't go far enough, are developing bills that go far

beyond the Bioshield law.

The new proposals would apply to a wider array of products, including ones

that treat such infectious diseases as severe acute respiratory syndrome and

avian influenza. And they would offer companies new protection from

lawsuits, tax incentives to help fund research and production as well as

various patent protections.

The most contentious idea, called wild-card exclusivity, is being pushed by

Sen. ph Lieberman, a Connecticut Democrat. Under his plan, a drug maker

that successfully develops a product to prevent or treat a bioterrorism

illness or emerging infectious disease could get six months to two years of

additional patent life for any product it chooses. As supporters explain it,

if Pfizer Inc., for example, invented an effective new antibiotic or joined

forces with a smaller biotechnology company to produce a new treatment for

botulism, it could get more time to sell blockbuster drugs such as Viagra or

cholesterol-lowering Lipitor without competition from cheaper generic

rivals. Blockbuster drugs, which usually have numerous patents, can generate

billions of dollars a year in sales.

Mr. Lieberman says incentives such as the wild-card provision are needed to

entice big drug companies to join in fighting bioterrorism threats -- a

riskier and less-profitable business than traditional pharmaceuticals. " We

are currently unprepared to respond to a bioterror attack and some

infectious-disease outbreaks, " he says. " We're racing against the clock. " He

plans to introduce the bill, which is likely to be co-sponsored by Sen.

Orrin Hatch, a Utah Republican, soon.

Supporters say wild-card exclusivity would be extended only to manufacturers

who deliver successful products. But generic-drug makers say instead that

the bar to gain the extended patent protection would be much lower.

Passage of the wild-card measure is far from assured. Many lawmakers are

wary, and brand-name drug companies are split. But there is broad support

and momentum in Congress this year for legislation providing additional

rewards for large drug makers either to develop bioterrorism countermeasures

or to help smaller biotech firms produce them on a large scale.

" If you're building a biodefense industry, you've got to send a signal that

this is for real, " says Rapoport, a partner with McKenna, Long &

Aldridge, a law firm that represents drug and vaccine companies that

contract with the government.

Generics makers say the wild-card proposal would drive up drug costs by

delaying the entry of cheaper copies to the market. The plan " would allow

the brand industry to reach into the medicine cabinet of every American and

unfairly extend exclusivity on the drug of their choice, " says Kathleen

Jaeger, president and chief executive of the Generic Pharmaceutical

Association, the Washington trade group for the industry.

Backed by employer groups and insurance companies -- which say the wild-card

idea would drive up drug costs -- the generic industry is waging an

offensive on Capitol Hill. Other critics say that Medicare, the federal

health program for the elderly, and Medicaid, the state health program for

the poor, would end up paying more for drugs if generic rivals to popular

drugs were delayed.

Pfizer says it backs the wild-card proposal and other patent-related

incentives as a way to " induce large companies to invest capital and divert

the necessary resources to develop promising compounds for countermeasure

uses, " says company spokesman Jack . Last year's Bioshield law " isn't

enough to spur the development of new drugs to counter bioterrorism

attacks. "

Other big name-brand drug companies and the Pharmaceutical Research and

Manufacturers of America, the industry trade group, say they aren't taking a

position on the wild-card or other intellectual-property proposals.

The debate will come to a head in the next few months. Republican leaders in

the Senate have introduced a bioterrorism bill, S.3, that they say doesn't

include the wild-card idea. It " seemed from our perspective to be a

non-starter, " says Gayle Osterberg, a spokeswoman for Sen. Judd Gregg, a New

Hampshire Republican and the lead sponsor. Some who have seen the bill say

its language is ambiguous; generic-industry experts say it contains the

wild-card provision.

In any case, the generics industry objects to other patent provisions in

S.3. The legislation would allow the government to award drug companies as

much as two years of extra market exclusivity on existing products if they

are used in an emergency. An example would be Bayer AG's Cipro, an

antibiotic the government purchased during the 2001 anthrax attacks. Under

S.3, the Health and Human Services Secretary could reward Bayer with two

extra years to sell Cipro exclusively. In a second possible incentive, the

legislation would let the government grant extra patent protection for

bioterrorism or infectious-disease drugs equal to the amount of time the

manufacturers spend waiting for approval from the Food and Drug

Administration. Companies wouldn't be able to get both types of extensions,

supporters said.

The generic industry contends that S.3 goes further than its Senate sponsors

are willing to admit. Ms. Jaeger says, for example, that the definition of

products that could qualify for extra exclusivity is overly broad and could

be applied to blood-pressure or anti-anxiety drugs used to treat the

secondary effects of a bioterror attack. She argues that companies should be

encouraged to make novel products rather than be rewarded for existing ones.

Makers of generics support tax incentives and liability protections rather

than patent extensions on brand-name drugs. They are joined in the fight by

the Coalition for a Competitive Pharmaceutical Market, a group that includes

insurers and employers such as General Motors Corp. and Caterpillar Inc., as

well as generic drug makers.

Wild-card exclusivity, also called transferable exclusivity, has been

promoted in the past by representatives of the brand-name industry as a way

to stimulate research in less-profitable areas such as diseases affecting

the developing world and medications for children.

These days, PhRMA says it is most interested in proposals to protect makers

of bioterror products from liability suits. Brand-name drug maker Merck &

Co. says it isn't lobbying for the wild-card proposal. To get larger

companies involved in bioterrorism research, " we think the two critical

issues are a strong, guaranteed purchase commitment and liability

protection, " says Ian Spatz, Merck's vice president for public policy.

GlaxoKline PLC has proposed the wild-card idea internationally as a way

to encourage research on diseases that affect the developing world. But the

brand-name drug company is " not lobbying actively " for its inclusion in this

year's bioterrorism legislation, says spokeswoman Anne Rhyne. She

adds, " We're interested in seeing what the proposal actually turns out to

be. "

Write to Lueck at sarah.lueck@...

URL for this article:

http://online.wsj.com/article/0,,SB111231124197694876,00.html

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