FDA is Selling the Brooklyn Bridge

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SSRI-Research@

Thu, 19 Jan 2006 20:49:13 -0500

[sSRI-Research] FDA is Selling the Brooklyn Bridge

 

 

 

FDA is Selling the Brooklyn Bridge

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The rationale given by FDA's deputy commissioner for medical and

scientific affairs, Scott Gottlieb, for FDA's proposed rule asserting

federal preemption, demonstrates that Dr. Gottlieb has either been on

a dessert island these last 5 years or he has been hired to lead the

FDA publifc deception committee: deceiving the public with a bill of

goods:

 

" We think that if your company complies with the FDA processes, if you

bring forward the benefits and risks of your drug, and let your

information be judged through a process with highly trained

scientists, you should not be second-guessed by state courts that

don't have the same scientific knowledge. "

 

 

Who is kidding whom when documents reproduced on the internet and in

newspapers such as the Wall Street Journal reveal in black and white

that FDA-approved drug labels DO NOT tell the truth about the risks.

In fact, they lie.

 

This issue is NOT about trial lawyers, this issue is about the rights

and health, and safety of ordinary citizens.

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

 

FDA Tries to Limit Drug Suits in State Courts

Agency's 'Federal Preemption' Policy Included in Labeling Guidelines

for Medications

By Marc Kaufman

Washington Post Staff Writer

Thursday, January 19, 2006; Page A02

People who believe they were injured by drugs approved by the Food and

Drug Administration should not be allowed to sue drug companies in

state courts, the agency said yesterday in a formal policy statement.

 

The FDA's controversial assertion of " federal preemption " was included

as a preamble to long-awaited guidelines designed to make drug

labeling information more accessible and readable for doctors and

consumers. Agency officials said that though the preemption policy

does not have the weight of law or formal regulation, they hope state

judges will accept their position.

 

" We think that if your company complies with the FDA processes, if you

bring forward the benefits and risks of your drug, and let your

information be judged through a process with highly trained

scientists, you should not be second-guessed by state courts that

don't have the same scientific knowledge, " said Scott Gottlieb, the

FDA's deputy commissioner for medical and scientific affairs.

 

The new labeling rules require drugmakers to highlight the most

important advisory information in the " package insert " issued with

every prescription and to cut back on the often-technical legal

language that officials said is included more to protect drugmakers

from lawsuits than to inform doctors and patients. Gottlieb said drug

industry officials convinced the agency that they deserved more

broadly stated FDA support because the new, more streamlined labeling

would make them more vulnerable to lawsuits.

 

While the new labeling guidelines were widely applauded yesterday, the

claim of federal preemption was quickly attacked by trial lawyers and

members of Congress as another effort by the Bush administration to

limit the public's ability to bring and win lawsuits.

 

Without state product liability laws, the critics said, drug companies

could escape responsibility for injuries and deaths caused by drugs

such as Merck & Co.'s Vioxx, which an FDA medical officer estimated

had killed as many as 55,000 Americans.

 

" Eliminating the rights of individuals to hold negligent drug

companies accountable puts patients in even more danger than they

already are in from drug company executives that put profits before

safety, " said Ken Suggs, president of the Association of Trial Lawyers

of America.

 

" The fact that the drug industry can get the FDA to rewrite the rules

so that CEOs can escape accountability for putting dangerous and

deadly drugs on the market is the scariest example yet of how much

control these big corporations have over our political process, " he said.

 

Anticipating that the FDA would make the preemption claim, the

National Conference of State Legislatures, a bipartisan group that

represents state legislators, said last week that the agency was

seizing authority that it did not have. Yesterday, Sen. Edward M.

Kennedy (D-Mass.) expanded on that criticism.

 

" It's a typical abuse by the Bush Administration -- take a regulation

to improve the information that doctors and patients receive about

prescription drugs and turn it into a protection against liability for

the drug industry, " he said in a statement.

 

The Bush administration has intervened in a number of state liability

cases against drug and medical device manufacturers with

friend-of-the-court briefs supporting the companies. Yesterday's

policy statement was just a way to make the same points on a broad and

general basis, Gottlieb said.

 

The drug labeling guidelines were first proposed as a new regulation

in December 2000 and have been subject to years of debate and public

hearings. The new guidelines -- which will go into effect on June 30

-- were announced yesterday by Surgeon General Richard H. Carmona and

top FDA officials, who called them a major public health advance.

 

" Americans are overwhelmed with the complexity of health information.

We have hit a point of information overload, and the public health

message is being diluted, " Carmona said. " This is of great concern

when it comes to making sure a patient knows how to use prescription

drugs safely and effectively. This problem is compounded by

prescription medication information that reads more like legal

disclaimers than useful or actionable health information. "

 

The new labeling -- the first revision of its kind in 25 years -- is

required for all new drugs that come on the market and those approved

in the past five years. Officials said the new " highlights " section

and a table of contents that organizes the information will help avoid

some of the estimated 300,000 preventable drug-related complications

reported in hospitals, many of which are the results of confusing

medical information.

 

Although the new labeling will make it easier for doctors to digest

information about the drugs they prescribe, consumers may not find it

much more accessible. The patient information leaflets written in

laymen's language that patients receive with their prescriptions are

commercially produced and not approved or scrutinized by the FDA.

 

Sidney Wolfe, director of Public Citizen's Health Research Group, said

patients should get the new, FDA-approved labeling information as well.

 

" It is time to end the double standard where doctors and other health

professionals are informed by FDA-approved labeling, but patients are

treated like second-class citizens, receiving whatever the

out-of-control purveyors of patient information leaflets choose to

dispense, " he said.

 

 

 

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