Goozner - Our Polite FDA

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Fri, 27 Jan 2006 16:43:33 -0500

[sSRI-Research] Goozner - Our Polite FDA

 

 

 

 

Here gang member Merrill Goozner documents yet another sweetheart deal

between the FDA and the industrial complex it is mandated to police.

It goes way beyond the worrysome when one realizes it is the

incestuous embedded culture and corporate greed that encourages and

rewards this kind of bureaucratic behavior.

 

 

http://www.gooznews.com/archives/000265.html

 

January 27, 2006

Our Polite FDA

First they waited until the bidding war was over, then they asked them

to tea.

 

The Food and Drug Admininstration yesterday called a press conference

to release a scathing letter attacking Boston Scientific's top

management for failing to track and report deaths and injuries caused

by faulty medical devices. Even though agency inspectors had been on

Boston Scientific's case throughout the past year, the FDA leadership

waited until just one day after the company won a $27 billion bidding

war to buy rival Guidant Corp. before demanding a meeting with the

company's top management.

 

The agency told the press the timing of the latest warning letter,

dated Jan. 25, and its release the next day, had nothing to do with

the buyout, which was announced the same day the letter went out.

 

What did Boston Scientific do wrong? In essence, they failed to

analyze incoming complaints about deaths and illnesses caused by some

its devices. More importantly, it failed to report them to the FDA.

According to the letter, the devices included the widely used

paclitaxel-eluding stent for cardiovascular disease.

 

Anyone interested in the details of the complaint can find it here.

The most significant paragraphs came near the end where the FDA

announced its penalties. The FDA said it would stop granting Boston

Scientific new approvals or export licenses, which could hurt the

company's business down the road.

 

What didn't it do? It did not slap immediate financial penalties on

the company even though it could have seized inventory, obtained a

court order forbidding further marketing of its products or assessed

civil penalties " without further notice to you. "

 

Instead, the FDA gave top management until Feb. 3 to prepare for

another meeting with the FDA inspectors. Another day, another warning.

The first warning letter to Boston Scientific with findings of

" systematic failure " to analyze and report flaws in its devices went

out last May. Follow-up inspections that resulted in additional

warning letters took place in August and September.

 

In recent months, the Institute of Medicine (at the FDA's request) has

been studying the FDA's inadequate system for tracking adverse events

after it has approved a drug. If this latest window into the world of

medical devices is any indication, the system for tracking

manufacturing flaws is just as bad if not worse.

 

Posted by gooznews at January 27, 2006 04:44 AM