Forbes.com Matthew Herper describes the distorted image of the director of the FDA’s Oncology and Hematology Products, Dr. Richard Pazdur, as the villain to cancer treatments by his critics. In an interview he gave at the annual American Society of Clinical Oncology, the portrayal shifted to his reality, his standards, and pushes to bring cancer therapies to the public. Pazdur commented about the rising amounts of cancer drugs approved, “We don’t have a lot of questions on drugs because they’re slam dunks. It’s not if we’re going to approve them. It’s how fast we’re going to approve them.” Quick approvals are also being aided by a new “breakthrough” designation, which was spurred by the FDA Safety and Innovation Act of 2012. The new breakthrough designation applies to treatments for life threatening diseases such as various forms of cancer. The breakthrough designation is different than some of the other accelerated process designations because it allows the companies to call in more times and get a clear schedule to work with the FDA. Pazdur claims that there must be a difference in communication level for the entities that receive the breakthrough status, otherwise it is worthless. For the full article click here.
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