FDA's counsel accused of being too close to drug industry

[Guest guest]

http://bmj.bmjjournals.com/cgi/content/full/329/7459/189

 

BMJ 2004;329:189 (24 July),

doi:10.1136/bmj.329.7459.189

 

FDA's counsel accused of being too close to drug

industry

Jeanne Lenzer

 

New York

 

Daniel Troy, chief counsel to the US Food and Drug

Administration, is under fire for inviting drug

companies to inform him of lawsuits against them so

the FDA could help in their defence. " We can't afford

to get involved in every case—we have to pick our

shots, " he said, advising them therefore to " make it

sound like a Hollywood pitch. "

 

Congressman Maurice Hinchey of New York charges Mr

Troy with a " pattern of collusion " with drug and

medical device manufacturers. Mr Hinchey told the BMJ

that the FDA had " corrupted its mission to protect the

public health " and that Mr Troy " is aggressively

intervening against the public on behalf of drug

companies and medical device manufacturers. "

 

Mr Troy's supporters insist that it has been necessary

for him to involve himself in court cases to protect

the interests of the FDA. The agency says that court

plaintiffs are intruding more heavily on the FDA's

primary jurisdiction than ever before and it wants to

ensure that it maintains its right to determine the

labelling requirements for drugs and medical devices.

 

Mr Troy is one of over 100 industry advocates who have

become regulators under President George W Bush's

administration. Although recent counsels for the FDA

were civil servants, President Bush made a political

appointment by naming Mr Troy as chief counsel on 21

August 2001. President Bush has received substantial

funding from drug companies (19 June, p 1458).

 

Before coming to the FDA, Mr Troy was with the law

firm Wiley Rein & Fielding in Washington, DC, where he

advanced the interests of drug and tobacco companies

against the FDA. In 1993, he was successful in a suit

that forced the FDA to relax its rules prohibiting

drug companies from promoting off-label prescribing.

 

Since coming to the FDA, Mr Troy has filed briefs

defending four companies, including Pfizer, SmithKline

Beecham Consumer Products, and GlaxoSmithKline,

arguing the side of the defendant corporation against

people who were suing for damages after using that

corporation's product.

 

Pfizer had been one of Mr Troy's clients, and Mr

Hinchey charges that Mr Troy hid and minimised his

ties to Pfizer by failing to report to Congress that

he had been paid $358 000 (£192 000; {euro}290 000) by

Pfizer in 2001—the same year he was appointed to the

FDA. Mr Hinchey said that Mr Troy then minimised his

role, saying he only worked some 80 hours for Pfizer

annually. " That's $4475 per hour, " said Mr Hinchey,

who said that Mr Troy was either very well paid or

obfuscating his involvement with the company.

 

Mr Troy and the FDA have declined to respond to media

inquiries, but the acting commissioner of the FDA,

Lester Crawford, issued a news release saying that Mr

Troy is a " talented public servant who has provided

excellent legal advice to FDA since his appointment. "

 

An FDA official told the BMJ that the reason for Mr

Troy's interest on behalf of drug and medical device

manufacturers is justified because of the right to

" pre-emption " in which federal law pre-empts local and

state laws. " FDA [must have] primacy over the package

insert. The package insert is the primary way the FDA

informs doctors about what is safe and effective. " She

added: " If you over-warn, you scare people away; if

you under-warn, you expose people to risk. "

 

Five former chief counsels to the FDA signed a letter

to Congress in support of Mr Troy and pre-emption,

saying that if " every state judge and jury could

fashion their own labeling requirements for drugs and

medical devices, there would be regulatory chaos for

those two industries that are so vital to the public

health. "

 

But Mr Hinchey disagrees, saying that drug companies

" compile the data given to the FDA, and sometimes,

when adverse consequences happen, they keep that

information to themselves. " That, says Mr Hinchey,

makes it necessary to protect the right of injured

citizens to seek compensation for their care.

 

Dr Sidney Wolfe of Public Citizen told the BMJ that

the FDA now views industry, instead of just the

public, as its client—a problem, he says, that is

exacerbated by political appointments and by the

Prescription Drug User Fee Act, which uses industry

fees to pay for the review of their products.

 

 

Maurice Hinchey (above) accused Daniel Troy of

collusion

 

Credit: JIM McKNIGHT/PA

 

Mr Hinchey introduced an amendment to take $500 000

away from Mr Troy's office and add it to the Drug

Evaluation Research budget to counteract false and

misleading advertising. The US House passed the

amendment unanimously.

 

A spokesman for the FDA said that it was not the FDA

that filed briefs that have been described as

defending Pfizer; it was the Department of Justice

that did. Moreover, the briefs defended the

government's own interests, not Pfizer.

 

In addition, the payment of $358 000 by Pfizer was not

to Mr Troy himself but to his firm.

 

 

Other related articles in BMJ:

 

News

Bush plans to screen whole US population for mental

illness.

Jeanne Lenzer

BMJ 2004 328: 1458. [Full text]