FDA's New Year Gift to Big Pharma

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Thu, 19 Jan 2006 20:49:52 -0500

[sSRI-Research] FDA's New Year Gift to Big Pharma

 

 

 

FDA's New Year Gift to Big Pharma

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The FDA has issued new rules to shield the drug manufacturers from

liability from harm encouraging the marketing of defective drugs that

have induced debilitating life-threatening chronic diseases such as

diabetes (Zyprexa, Risperdal). And immunity from marketing outright

lethal drugs (such as Vioxx, FenPhen--which the FDA had approved and

whose labels when they were marketed did not warn consumers about the

risks.

 

FDA's new rule provides the avenue for shutting the door of justice

in consumers' faces.

 

" not only an end-run around current law but also a broad extension of

the Bush administration's effort to push for tort reform with respect

to product liability. This initiative puts to rest any doubts that FDA

decision-making has become politicized, "

 

See Wall Street Journal report, Jan. 15 at::

http://www.ahrp.org/cms/content/view/34/1/

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

Science & Integrity: Center for Science in the Public Interest

 

Six Years of Study, And Then FDA Exempts Most Drugs from New Labeling

Rules

 

January 18, 2006

Merrill Goozner

 

The Food and Drug Administration trotted out its long-awaited new

labeling rules today, and, as expected, did a major favor for drug

companies facing liability lawsuits while exempting drugs older than

five years from its requirements.

 

The purpose of the new labeling rule, the first major revision in 25

years of the package inserts given with all drug prescriptions, is to

provide physicians and consumers with clear and concise information

about the uses, side effects and potential dangers of FDA-approved

medicines. FDA deputy director Janet Woodcock said the old package

inserts containing scientific gobbledegook that most patients

immediately throw in the garbage will soon be replaced with printed

inserts whose information will be as easily read as the nutrition

labels on food. The labels will also be posted on the web at a new

website.

 

Sounds good. But the problem is that there was nothing in the new

regulation that required drug companies with products over five years

old from complying with the new rule. Since the drug industry's output

of new drugs has been rather low of late, the vast majority of drugs

in widespread use will not be covered by the new rule.

 

Moreover, one physician on a " stakeholders " conference call pointed

out that many labels on older drugs -- he gave the example of HIV/AIDS

drugs approved before the development of triple-cocktail therapy --

contain outdated information about the best uses of the drug, even if

the label isn't technically incorrect. " If there is new information

that causes the label to be false or misleading, then it should be

revised, " said Rachel Behrman, deputy director of the Office of

Medical Policy at FDA. " But there is nothing in the rule requiring it. "

 

Meanwhile, as the Wall Street Journal reported last Friday, the

preamble of the rule contained a clause that said states cannot pass

labeling rules that demand companies print more information than the

FDA requires. Many product liability lawsuits against drug companies

rest on the claim that the company failed to warn about hazards

because they failed to comply with state labeling statutes.

 

One Washington law firm described the federal preemption language in

the new rule as " not only an end-run around current law but also a

broad extension of the Bush administration's effort to push for tort

reform with respect to product liability. This initiative puts to rest

any doubts that FDA decision-making has become politicized, " said Ira

Loss and Beth Steindecker, attorneys at Washington Analysis.

 

When questioned by reporters, deputy director Scott Gottlieb, the Bush

administration's second highest ranking political appointee at the

agency, tried to downplay this gift to the drug companies. " This is

just a rearticulation of a policy that the FDA has filed in various

amicus briefs over two administrations, " he said.

 

It's true that Big Pharma has exerted extraordinary control over the

FDA legal counsel office in the past decade. One of former Vice

President Al Gore's top advisers hailed from Genentech, a leading

biotech firm.

 

However, this drug industry influence over legal affairs at the agency

skyrocketed during the first Bush term when former industry lawyer Dan

Troy assumed the top lawyer job at the agency. He is now back at his

old firm representing industry clients.

 

The revised labeling rule was initially proposed in 2000 during the

waning days of the Clinton administration. That version did not

contain the preemption language.

 

Posted by gooznews at 05:49 PM

 

 

http://online.wsj.com/article/SB113760135744049798.html

THE WALL STREET JOURNAL

January 19, 2006 Lawyers May Change Their Tactics In Drug Liability Cases

By HEATHER WON TESORIERO and ANNA WILDE MATHEWS

 

 

 

Copyright 2006 Dow Jones & Company, Inc. All Rights Reserv

 

 

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