Serious Flaw in FDA's Complex Regulatory Structure

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Fri, 12 Nov 2004 20:08:09 -0500

[sSRI-Research] Serious Flaw in FDA's Complex Regulatory

Structure

 

Serious Flaw in FDA's Complex Regulatory Structure

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness and Full Disclosure

http://www.ahrp.org

 

Bloomberg News reports that New York State Attorney General Eliot Spitzer

requested information from Pfizer about the promotion of some of its drugs

for unapproved uses-the recalled diabetes drug, Rezulin and the

antidepressant, Zoloft were named.

 

In what is surely the understatement of the decade, FDA's director of the

Center for Drug Evaluation and Research (CDER) acknowledged:

 

" Our current drug approval system has demonstrated that we don't always

understand the full magnitude of drug risks prior to approval of drug

products. "

 

The FDA is under intense criticism following disclosure that the

agency time

and again failed to detect evidence of lethal drug hazards or to issue

appropriate Black Box warnings to protect the public when such hazards

were

identified by the agency's own experts-has led senior FDA officials to

scramble for cover. The Washington Post and New York Times report

that FDA

officials have made several announcements to demonstrate a willingness to

concede imperfection.

 

See: Marc Kaufman and Brooke A. Masters. FDA pledges to listen to

dissenting scientists

 

 

The Washington Post

Saturday, November 06, 2004

http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

 

However, none of the proposed measures would address the inherent

overriding

problems that plague the agency. An insightful, hard hitting editorial in

The Lancet points to an essential problem that the agency fails to

address:

" The inherent precedence that licensing of new drugs takes over safety

evaluation is a serious flaw in FDA's complex regulatory structure. "

 

FDA's failure to identify and to warn the public about the " full magnitude

of drug risks " is rooted in the fact that the FDA has given priority

to the

business interests of pharmaceutical companies--rather than public safety

issues. Indeed, the agency has left the Office of Drug Safety without a

director for over a year. The FDA has failed to fulfill its mission by

pretending not to know that drug companies were concealing lethal side

effects because disclosing the " full magnitude of drug risks " is risky for

business.

 

The FDA has yet to act or even to respond to AHRP's complaint about the

failure of Pfizer to comply with FDA's suicide disclosure requirements

in a

two page advertisement for its antidepressant, Zoloft, in The New York

Times

Magazine (October 24, 2004).

 

Public announcements do not substitute for enforcement of safety

requirements. When a public oversight agency fails to perform its

mission--protecting the public from hazardous drugs--its leadership

must be

held accountable and a thorough overhaul is called for.

 

The foremost objective must be to rid the drug evaluation process of

conflicts of interest. Conflict of interest is like graft--it can't be

contained-if tolerated, it corrupts the entire enterprise.

 

The FDA announced that it would contract the Institute of Medicine to

convene a panel to assess FDA's handling of dangerous side effects.

Unless

that panel is free of conflicts of interest, its assessment will not be

credible.

 

 

Unless there is zero tolerance for conflicts of interest in the drug

safety

assessment process and unless the process becomes transparent--public

health

is in jeopardy. To ensure that the drug review and approval process

is not

tainted--all voting members on FDA's advisory committees must be free of

conflicts of interest. All FDA's consultants' financial ties to industry

must be disclosed. No more waivers of financial disclosure.

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

BLOOMBERG NEWS

 

Pfizer Says New York's Spitzer Requests Information

(Update2) 2004-11-05 19:21 (New York)

By Nicole Ostrow and Marni Leff Kottle

 

Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker,

said New

York State Attorney General Eliot Spitzer requested information about the

promotion of some of its drugs for unapproved uses.

 

Pfizer, based in New York, said Connecticut Attorney General Richard

Blumenthal also requested materials on so-called ``off-label''

promotion of

its Zoloft antidepressant. The company disclosed the probes in a

regulatory

filing. Doctors sometimes prescribe medications for applications that

haven't been approved by U.S. regulators. While such use is legal,

promotion of drugs for off-label use isn't.

 

Pfizer's Warner-Lambert unit in May agreed to pay more than $430

million to

settle U.S. charges that it promoted its Neurontin epilepsy drug for

unapproved uses.

 

Pfizer spokesman Paul Fitzhenry said he couldn't provide additional

comment

beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as

of 4:17

p.m. in New York Stock Exchange composite trading. They have fallen 19

percent this year. Pfizer also said it has given the Justice

Department and

the U.S. Securities and Exchange Commission information related to an

internal investigation the company is conducting in Croatia. The inquiry

involves ``certain potentially improper payments made in connection with

foreign sales activities in Croatia,'' Pfizer said in the filing.

 

Fitzhenry said he couldn't provide further details. The U.S. Attorney's

office for the District of Maryland told Pfizer in an Oct. 13 letter that

it has closed its investigation related to sales of the Rezulin diabetes

drug, according to the filing. Pfizer acquired Rezulin when it bought

Warner-Lambert in 2000. Rezulin has been the subject of

personal-injury lawsuits, claiming

the drug damaged some patients' livers. The drug was taken off the market

in 2000. Pfizer in last year's fourth quarter had $955 million in

costs as

it set aside money to resolve claims over Rezulin.

 

--With reporting by Susan Decker in Washington.

Editors: Simison, Todd.

 

 

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