Dr. Estey Discusses the FDA Approval Process

December 18, 2013
Elihu H. Estey, MD

Elihu H. Estey, MD, professor of medicine, University of Washington School of Medicine, Fred Hutchinson Cancer Research Center, discusses a potential change to the FDA approval process as it relates to Mylotarg (gemtuzumab ozogamicin).

Elihu H. Estey, MD, professor of medicine, University of Washington School of Medicine, Fred Hutchinson Cancer Research Center, discusses a potential change to the FDA approval process.

There is a school of thought, Estey says, that states that the oncology community does not know much about a new drug until patients can actually use it. The question remains as to whether or not the FDA approval process should be changed. Estey says that a process could be put in place where if nothing suggests a drug is harmful, it could be pre-approved in an effort to collect a large amount of information and make it available to patients. This hypothetical process could be helpful to drug companies as well. Since companies currently have to conduct trials outside the U.S., this process could help get the drug into more patients. Estey says that this hypothetical process could also benefit community physicians, as they could learn about new drugs before administering them into their own patients.


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