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: TortDeform.com

NYT Op Ed: Time for FDA Overhaul

By Kia Franklin

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Back in December I aired my hopes that with a new year and new administration we'd see a new approach to regulation by the FDA and other agencies charged with protecting the public's health. The NYT editorial board agrees:

The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over. Officials will also have to make clear that the Bush administration?s practice of distorting science and weakening regulation to favor industry also is over.
...The next F.D.A. commissioner should ensure that past decisions on medical devices were properly made. Given its sorry performance in so many areas important to public health and safety, the agency is ready for a major overhaul.

Full post as published by TortDeform.com on January 27, 2009 (boomark / email).

Lawsuits and Settlements

Cipro
The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin. The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...

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