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Drug Safety Reform: Did FDA Buy Time or Trouble?

Executive Summary

FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.

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Lost in Translation: Interpreting Advisory Committees

FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.

FDA Safe at Home: Looks Inside for Top Safety Official

After a tumultuous, two-year hiatus, FDA finally has a permanent director for the Office of Drug Safety. Gerald Dal Pan, MD, succeeded Victor Raczkowski, ending a drawn out serach for what is increasingly becoming a politically sensitive middle management job within FDA.

Drug Safety, the Sequel: This Time It's Specialist Products

The withdrawal of Biogen Idec Inc. and Elan Corp.'s natalizumab (Tysabri) multiple sclerosis treatment just weeks after its introduction showed that specialist products aren't immune from serious safety issues. Sales and clinical trials of the drug were suspended with the cooperation of the FDA after two patients in the companies' clinical study of Tysabri in combination with Avonex developed the rare and often fatal demyelinating disorder PML.

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