FDA fell to lawmakers

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Like this s any surprise:

I tend to side with sports injury docs ...so the last paragrpah nailed

it for me...

September 25, 2009

F.D.A. Reveals It Fell to a Push by Lawmakers

By GARDINER HARRIS and DAVID M. HALBFINGER

WASHINGTON — The Food and Drug Administration said Thursday that four

New Jersey congressmen and its own former commissioner unduly

influenced the process that led to its decision last year to approve a

patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many

years decided that the device, known as Menaflex and manufactured by

ReGen Biologics Inc., was unsafe because the device often failed,

forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,â€

“unusual†and persistent pressure from four Democrats from New Jersey —

Senators Menendez and R. Lautenberg and Representatives

Pallone Jr. and R. Rothman — agency managers overruled the

scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of

receiving significant campaign contributions from ReGen, which is based

in New Jersey, but all said they had acted appropriately and were not

influenced by the money. Dr. C. von Eschenbach, the former drug

agency’s commissioner, said he had acte

d properly.

The agency has never before publicly questioned the process behind one

of its approvals, never admitted that a regulatory decision was

influenced by politics, and never accused a former commissioner of

questionable conduct.

“The message here is that there were problems with the integrity of

F.D.A.’s decision-making process that have solutions,†Dr.

Sharfstein, the agency’s principal deputy commissioner, said in a

conference call with reporters.

Dr. Sharfstein said that patients in the United States who had already

received the $3,000 device should wait for the agency’s review of the

device’s approval and urged them “not to panic.â€

Gerald E. Bisbee Jr., chairman and chief executive of ReGen, said that

Menaflex was safe and described as “inaccurate†many of the agency’s

characterizations of the device’s approval. Thirty patients in the

United States and nearly 3,000 in Europe have received the device, and

ReGen has trained up to 140 surgeons in the United States to use it. He

defended the company’s appeal to lawmakers.

“We did what people do all the time in Washington: we went to our

congressmen, we went to our senators,†Mr. Bisbee said.

Menaflex is a C-shaped pad used to repair a torn or damaged meniscus,

the cushion between knee bones. A clinical trial of the device failed

to show that it worked any20better than routine surgery.

The report, written by top agency officials, said that Dr. von

Eschenbach, who resigned as F.D.A. commissioner in January, became as a

result of political pressure “personally engaged in the details of a

process usually coordinated†by scientific staff. One agency manager

concluded that Dr. von Eschenbach “was demanding not only an expedited

process but also an outcome in favor of ReGen,†the report stated.

“Congressional interest in the ReGen matter — and the unusual

responsiveness of the commissioner to that interest — initiated a

chaotic new phase in the agency’s handling of the†company’s

application, the report said.

In an interview Thursday, Dr. von Eschenbach defended his actions.

“My responsibility as that process was coming to a close was to make

sure that it was continued in an orderly and appropriate fashion, and

that’s what I believe I did,†he said.

The F.D.A.’s report said that its Office of Legislation began receiving

calls from members of Congress in December 2007 complaining about its

review of the device, and the office’s director “described the pressure

from the Hill as the most extreme he had seen.â€

All four members of Congress denied that ReGen’s political

contributions had played any role in their efforts on its behalf with

the F.D.A. and said they were

merely doing their jobs by trying to help

a constituent company.

The four representatives received a total of $26,000 from three ReGen

executives beginning in October 2007, according to OpenSecrets.org. The

donations began with $2,000 to a political action committee controlled

by Mr. Menendez, the New Millennium PAC, on Oct. 28, 2007. Mr. Menendez

received another $7,100 for his campaign account in March 2008.

Afshin Mohamadi, a spokesman for Mr. Menendez, said the senator’s

“contact with the F.D.A. was to help to ensure that the agency was

communicating clearly with the company and to help ensure a fair

process.â€

Mr. Rothman, who represents Hackensack, where ReGen is based, said in a

statement that the company felt it was being “treated unfairly†and

that “today’s report makes it clear that the F.D.A. made mistakes and

communicated poorly with ReGen.â€

Mr. Rothman was given a $500 donation on Dec. 4, 2007; on Feb. 14,

2008, he received $8,200 for his campaign account and $2,600 for his

own political action committee, Renewing Opportunity, Trust & Hope, for

a total of $11,300 from the ReGen executives.

McGrath, a spokesman for Mr. Pallone, said the congressman had

simply asked that the F.D.A. “follow the law and make its decision

based on science.†Mr. Pallone received $2,300 in December 2007 and

$1,000 in October 2008 from a ReGen executive.

Caley Gray, a spokesman for Mr. Lautenberg, emphasized that the senator

“never made any calls or contacts†to ReGen Biologics, but did sign a

letter along with other members of the New Jersey delegation. Mr.

Lautenberg received $2,300 in May 2008 from a ReGen executive.

On Wednesday, the agency asked the Institute of Medicine to review the

entire process by which the agency approves the vast majority of

medical devices. The agency report was deeply critical of its device

approval process and said that confusion over basic rules and how to

resolve differences among reviewers was rife. For decades, most medical

devices have received only cursory reviews of their safety and efficacy

from the agency.

For equipment like bed pans and shower curtains, experts agree that

quick appraisals are appropriate. But the medical device industry is

producing more and more complex machinery like pacemakers and stents.

In January, the Government Accountability Office concluded that it was

long past time that the agency demanded that manufacturers prove that

all complex devices are safe and effective before being approved for

sale.

The agency’s report said that ReGen, like many devices, was approved

because it was supposed to be similar to an earlier device that itself

was approved because it was similar to another device. The result is a

“predicate creep,†the report said, in which devices are approved ba

sed

on information from older devices that often bear little resemblance to

each other.

Dr. R. Schmidt, the knee surgeon for the San Spurs, said

he was involved in the original clinical trial of ReGen’s Menaflex

device and concluded that patients did not benefit. He said he was

surprised that the F.D.A. approved it.

http://www.nytimes.com/2009/09/25/health/policy/25knee.html?em= & pagewanted=print