Sun Editorial:

Political pressure alleged

FDA says senators, representatives inserted themselves in approval process

Monday, Sept. 28, 2009 | 2:06 a.m.

The Food and Drug Administration, which has been under new management since Inauguration Day, is saying that an approval overseen by its former commissioner was influenced by political pressure.

In a conference call with reporters last week, the FDA’s principal deputy commissioner, Dr. Joshua Sharfstein, said a device for repairing worn-out knees was approved only after extreme pressure was brought by four members of New Jersey’s congressional delegation.

“The message here is that there were problems with the integrity of the FDA’s decision-making process,” Sharfstein said Thursday.

The agency, according to The New York Times, wrote in a report that scientific reviewers on its staff repeatedly and unanimously rejected Menaflex, the knee-repair device. It is manufactured by ReGen Biologics Inc., a New Jersey company. The reviewers found that the device often failed.

Beginning in December 2007, the FDA began receiving calls and letters in reference to the device from Democratic Sens. Robert Menendez and Frank Lautenberg and Democratic Reps. Frank Pallone Jr. and Steven Rothman.

Subsequently, according to an agency manager who helped write the report, then-FDA Commissioner Andrew C. von Eschenbach demanded “not only an expedited process but also an outcome in favor of ReGen.”

Although the approval is being reconsidered, the senators and representatives, along with von Eschenbach, have said they acted properly.

The report, however, makes the case that political pressure led to the approval of a device rejected as unsafe by scientific reviewers. If true, that would be more than improper — it would be outrageous.

Comments
Print
E-mail
Share
- Facebook
- Fark
- Digg
- Reddit
- Stumble
Tweet

Discussion: comments so far…

Comments are moderated by Las Vegas Sun editors. Our goal is not to limit the discussion, but rather to elevate it. Comments should be relevant and contain no abusive language. Comments that are off-topic, vulgar, profane or include personal attacks will be removed. Full comments policy. Additionally, we now display comments from trusted commenters by default. Those wishing to become a trusted commenter need to verify their identity or sign in with Facebook Connect to tie their Facebook account to their Las Vegas Sun account. For more on this change, read our story about how it works and why we did it.

Only trusted comments are displayed on this page. Untrusted comments have expired from this story.

No trusted comments have been posted.

By Future

Sept. 28, 2009

2:25 a.m.

Flag

"Beginning in December 2007, the FDA began receiving calls and letters in reference to the device from Democratic Sens. Robert Menendez and Frank Lautenberg and Democratic Reps. Frank Pallone Jr. and Steven Rothman."

All Democrats and the LV Sun claim there is new management and No influence.

When will the LV Sun learn
By neiman1

Sept. 28, 2009

7:37 a.m.

Flag

The Senators didn't care about the patients they were doing the bidding of a large business in their state that made huge campaign donations.

Democratic Party for the people? Just more of the same they just sell out to different companies.
By KillerB

Sept. 28, 2009

9:07 a.m.

Flag

Congressmen are our elected representatives. These Congressmen were just doing their jobs. It's called checks and balances, people, and one of the reasons the U.S. isn't quite a tyranny.

neiman1 -- full of yourself and ignorant as ever again, I see. "large business" means large employment, something Nevada could use a lot more of. Do the math. These Congressmen indeed acted properly.