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Diet Drug Report for March 2006 -- News About Diet Drugs
 
Will Nomination of Permanent FDA Chief Speed or Delay Acomplia?
 

The nomination by President Bush of acting Food and Drug Administration chief Andrew von Eschenbach to be permanent head of the FDA may be good news or bad news for Sanofi-Aventis as it seeks early approval of weight-loss drug Acomplia (rimonabant).

First, the good news scenario: Von Eschenbach, director of the National Cancer Institute before moving into the FDA position, has long taken the position that the FDA should speed up the drug approval process.

In a March 6th speech to the Personalized Medicine Coalition, von Eschenbach said he would make faster drug approvals "one of [his] highest priorities" as long as he is at FDA.

So the good news scenario for Sanofi might see von Eschenbach, as the President's nominee to be permanent head of the agency, push ahead with early approval of Acomplia for weight-management without seeing a need to wait for it to be considered by an agency advisory panel.

Then, the bad news scenario: The public debate over whether the FDA is doing enough to ensure drug safety is certain to become more contentious with the nomination of von Eschenbach to become permanent FDA commissioner.

There is no shortage of pent-up frustration and anger -- among Republicans as well as Democrats -- about the performance of the FDA in protecting public health and safety.

The Senate approval process for a new FDA commissioner is expected to be lengthy. Senate Finance Committee Chairman Charles Grassley, whose panel has oversight authority over the agency, is one of the lawmakers who has been very critical of the FDA.

Grassley has charged that both the FDA and Merck were aware that clinical trial results showed that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, but that the FDA did nothing until Merck took it off the market in 2004.

But Grassley's concern over the FDA and safety issues hardly stops there. He has repeatedly expressed concern about drugs with potential adverse side-effects being used to treat adolescents.

With National Institutes of Health researchers raising questions about Acomplia trial side effects that included a 2.7-fold higher rate of psychiatric disorders, is the FDA apt to rush ahead -- in the middle of the Senate confirmation process --to approve a drug subject to possible widespread misuse by overweight and obese teens.

Many long-time Washington observers think it highly unlikely.

 
 
 
 
 

 

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Last Updated: 03/16/2006 Copyright 2004-2006 Medical Week News, Inc. All Rights Reserved