BioPerspectives

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May 7, 2008

The FDA Scale-Up: Good for Big Pharma or Not?

  • Fact: the FDA relies on user fees since the 1990s with the goal of speeding up drug approvals, meaning it is severely underfunded by the federal government and has not been able to fulfill it's mission based on that alone...

    NOW the FDA wants to fill more than 1,300 posts in the upcoming months. Part of that are filling of empty positions already allocated (600), part are new positions that are being created (700) in order to better deal with the increase in drug applications and a more rigorous screening process.

    Thirty percent of regular FDA staffers are already eligible to retire, as are nearly half of FDA managers, does that strike anyone as worrisome after all the recent slip-ups (anyone remember Vioxx?) and the controversy over Pfizer trying to get access to reviewer names via court order?

    To be fair, the Pfizer incident is not directly linked to the FDA, but indirectly it is, namely why did this whole Celebrex business go to trial and not get caught by the FDA?

    As you can see there are more questions than answers and I want to know what do YOU think about the recent activities to improve the FDA?