FDA Modernization= Weaken Safety Enforcement

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[sSRI-Research] FDA " Modernization " = Weaken Safety Enforcement

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

The New York Times reports that an inquiry by Congressman Henry

Waxman found

that the number of warning letters issuede by the FDA to drug

companies,

medical device makers and others dropped 54% (535 in 2005 compared to

1,154

in 2000). The investigation found NO evidence of improved compliance

or

fewer violations!

 

" The investigation found that by almost every measure, enforcement

actions

had significantly declined from 2000 to 2005. The lone exception was

in the

number of products that had to be recalled from the market: that

increased

44 percent. "

 

" Since one of the goals of an enforcement system is to deter

violations and

keep dangerous products off of the market, " the report said, " the

increase

in recalls is not a hallmark of effective enforcement. "

 

A press release announces that FDA is embarking on " modernization " of

human

subject protections. This should raise red flags as it portends a

reduction

in monitoring thereby incfreasing dangers for human subjects in

clinical

trials. Faced with a shortage of volunteers, more and more vulnerable

persons -such as disabled, disadvantaged, or minors--are targeted for

conscription into clinical trials. The FDA has essentially abdicated

its

primary mission of protecting the public health.

 

The public is advised, therefore, to be ever more watchful about

every facet

of health care--clinical practice and clinical research--as the FDA

has

changed its role by casting its oversight to shield industry from

safety

standards.

 

" Americans have relied on F.D.A. to ensure the safety of their food

and

drugs for 100 years, " Mr. Waxman said. " But under the Bush

administration,

enforcement efforts have plummeted and serious violations are

ignored. "

 

Contact: Vera Hassner Sharav

212-595-8974

veracare <veracare

 

<http://view.atdmt.com/ORG/view/nwyrkfxs0040000007org/direct;at.orgfxs

000008

90/01/>

The New York Times

June 27, 2006

-

Top Democrat Finds F.D.A.'s Efforts Have Plunged

 

By GARDINER HARRIS

 

WASHINGTON, June 26 - A 15-month inquiry by a top House Democrat has

found

that enforcement of the nation's food and drug laws declined sharply

during

the first five years of the Bush administration.

 

For instance, the investigation found, the number of warning letters

that

the Food and Drug Administration issued to drug companies, medical

device

makers and others dropped 54 percent, to 535 in 2005 from 1,154 in

2000.

 

The seizure of mislabeled, defective or dangerous products dipped 44

percent, according to the inquiry, pursued by Representative Henry A.

Waxman

of California, the senior Democrat on the House Government Reform

Committee.

 

The research found no evidence that such declines could be attributed

to

increased compliance with regulations. Investigators at the F.D.A.

continued

to uncover about the same number of problems at drug and device

companies as

before, Mr. Waxman's inquiry found, but top officials of the agency

increasingly overruled the investigators' enforcement recommendations.

 

The biggest decline in enforcement actions was found at the agency's

device

center, where they decreased 65 percent in the five-year period

despite a

wave of problems with devices including implantable defibrillators

and

pacemakers.

 

" Americans have relied on F.D.A. to ensure the safety of their food

and

drugs for 100 years, " Mr. Waxman said. " But under the Bush

administration,

enforcement efforts have plummeted and serious violations are

ignored. "

 

David K. Elder, the director of the agency's Office of Enforcement,

explained that the F.D.A. had increasingly focused on the most serious

violations.

 

" As a result of F.D.A.'s focus on those firms and those violations

that

present the highest risk to consumers and public health, " Mr. Elder

said in

a statement, " the agency has taken prompt, targeted and aggressive

action

against firms that are in violation of law. "

 

Jack Calfee, a resident scholar at the conservative American

Enterprise

Institute, said the decline in the statistics was meaningless because

most

of the violations involved paperwork problems.

 

" I doubt that it makes a significant difference in the safety of

drugs or

other products, " Mr. Calfee said.

 

Mr. Waxman began his inquiry after Congressional hearings in 2004

suggested

that the agency was partly to blame for a shortage of flu vaccines.

His

staff requested thousands of documents from the F.D.A.

 

The investigation found that by almost every measure, enforcement

actions

had significantly declined from 2000 to 2005. The lone exception was

in the

number of products that had to be recalled from the market: that

increased

44 percent.

 

" Since one of the goals of an enforcement system is to deter

violations and

keep dangerous products off of the market, " the report said, " the

increase

in recalls is not a hallmark of effective enforcement. "

 

In one prominent case, in December 2000, a worker at a nursing home in

Xenia, Ohio, mistakenly hooked up a tank of nitrogen gas to the home's

oxygen delivery system. Four residents died.

 

In the months that followed, investigators for the agency concluded

that the

company that delivered the tanks, BOC Gases, was partly to blame for

the

mix-up, given what they deemed inadequacy of the company's own

controls and

employee training. Indeed, BOC had a " corporate-wide problem, " F.D.A.

documents at the time said. The investigators recommended

prosecution, but

the agency took no enforcement action.

 

Kristina Schurr, a spokeswoman for BOC, said that the company's

controls had

not been to blame but that in any case it had improved its procedures

since

then.

 

Several former top officials of the agency attributed the decline in

enforcement actions to budget problems.

 

" This is a tragedy, " said Peter Barton Hutt, a former general counsel

of the

F.D.A. who now represents drug companies and teaches food and drug

law at

Harvard . " Congress has failed to realize that our single most

important

government agency is being systematically dismantled. "

 

Dr. Sidney M. Wolfe, director of the Health Research Group at the

watchdog

organization Public Citizen, noted that the agency now received about

$380

million a year in fees from drug makers.

 

" The public, " Dr. Wolfe said, " is getting the kind of F.D.A . that the

industry is paying for them to get. "

 

~~~~~~~~~~~

 

FDA News

FOR IMMEDIATE RELEASE

P06-86

June 26, 2006

 

Media Inquiries:

Laura Alvey, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

 

FDA Announces New Initiative to Modernize the Regulation of Clinical

Trials

and Bioresearch Monitoring

 

The Food and Drug Administration (FDA) today announced a series of new

policy and regulatory developments to strengthen the Agency's

oversight and

protection of patients in clinical trials and the integrity of

resulting

data in an effort to modernize the agency's approach to bioresearch

monitoring as part of the Critical Path Initiative. The Human Subject

Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will

facilitate

the modernization of the regulation of clinical trials and bioresearch

monitoring, specifically the protection of human subjects and the

integrity

of data in clinical trials, and encompasses devices, foods, human

drugs,

biological drug products and veterinary medicine.

 

The new effort is part of an HHS-wide initiative to employ recent

advances

in basic science, including genomics and molecular analysis, in order

to

bring about more effective development and review of therapies, and to

enable increasingly targeted and individualized care management for

patients.

 

" As clinical trials continue to evolve, in particular becoming

increasingly

large, decentralized and global, the FDA's approach to bioresearch

monitoring and human subject protection must also evolve and

modernize, "

said Janet Woodcock, FDA Deputy Commissioner for Operations at this

year's

Drug Information Association annual meeting. " BIMO will help FDA

modernize

biomedical research monitoring making the most efficient use of its

resources to help ensure the safe conduct of clinical trials,

including

taking appropriate opportunities to leverage existing oversight done

by

private entities to accomplish the Agency's risk minimization goals. "

 

Clinical trials have evolved dramatically since FDA first began

inspecting

them in 1977. In an effort to protect the rights and welfare of human

subjects and to verify the quality and integrity of data submitted for

review, FDA established over time a bioresearch monitoring program

that

included the development and implementation of compliance programs to

provide guidance for inspections of investigators, sponsors, contract

research organizations, institutional review boards and bioequivalence

facilities. With the expansion of clinical trial studies and sites,

electronic record-keeping in the studies, and greater participation by

vulnerable subjects in clinical trials, the role of FDA's bioresearch

monitoring compliance programs must expand and evolve as well. The

HSP/BIMO

Initiative addresses that need.

 

Over the past year and a half, FDA has carefully inventoried its

programs

and identified issues to launch the HSP/BIMO Initiative. As this

initiative

moves forward, FDA will continue to gather additional issues for the

initiative and related information from internal and external

stakeholders,

e.g., industry, academic, and government activities and programs, and

intends to conduct workshops and create other opportunities for public

input.

 

Janet Woodcock, M.D., Deputy Commissioner for Operations, will chair

the HSP

/BIMO steering committee which is comprised of representatives from

the

Center for Biologics Evaluation and Research (CBER), Center for Drug

Evaluation and Research (CDER), Center for Food, Safety, and Nutrition

(CFSAN), Center for Veterinary Medicine ( CVM ), Office of Regulatory

Affairs (ORA), and the Office of the Commissioner (OC).

 

Highlights of what has been completed to date include:

 

Draft Guidance; Process for Handling Referrals to FDA Under 21 CFR

50.54; Additional Safeguards for Children in Clinical Investigations,

published May 2006

 

Guidance for Industry - Using a Centralized IRB Process in

Multicenter Clinical Trials, published in March 2006

 

Guidance for Clinical Trial Sponsors: Establishment and Operation of

Clinical Trial Data Monitoring Committees, published in March 2006

 

Information Sheet Guidances for IRBs, Clinical Investigators, and

Sponsors, five published in final January 2006

 

Projects in progress:

 

Modernizing adverse event reporting to institutional review boards

(IRBs) to accommodate major trend toward multicenter trials (March

2005,

held Part 15 Hearing - Adverse Event Reporting to IRBs, currently

working on

draft guidance)

 

Published proposed rule: Institutional Review Board - Registration

Requirements, FDA reviewing comments

 

Finalizing rule: Foreign Clinical Studies not Conducted Under an

IND (21 CFR 312.120)

 

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