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FDA Overhauls Prescription Drug Oversight Program

The Food and Drug Administration announced it is making more than a dozen changes to improve oversight of prescription drugs, including increased monitoring of drugs' safety after they are on the market. FDA Commissioner Dr. Andrew Von Eschenbach discusses the changes.

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    Ever since the popular painkiller Vioxx was pulled from pharmacy shelves over safety concerns, there's been heightened criticism of the way the Food and Drug Administration approves and monitors new drugs.

    Last fall, the Institute of Medicine issued a scathing report, saying the FDA's effectiveness is compromised by internal tensions, outdated procedures, underfunding, and poor management. The report took particular aim at the FDA's failure to adequately monitor drugs, it said, after they go on sale.

    Yesterday, after its own review, the FDA announced it was making more than a dozen changes to improve its drug oversight work. They include: creating a new system to monitor newly approved drugs once they come on the market; and giving agency staff involved in drug safety equal standing with staffers focused on drug approval.

    Here to tell us more now is the FDA's commissioner, Dr. Andrew von Eschenbach. And welcome, Doctor.

    DR. ANDREW VON ESCHENBACH, Food and Drug Administration Commissioner: Thanks, Margaret.


    Thanks for being here. Do you consider this a major overhaul in the way the FDA does its work?


    It's a major step forward in what will be an ongoing process of continuous improvement. The FDA has had a long history of being the world's gold standard for drug regulation and assuring the safety and effectiveness of drugs.

    But the world has changed. And we are in the midst of major changes in medicine, and so the FDA must continuously adapt to the future of health care and ensuring the safety of these products.

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