Regulatory Focus™ > News Articles > FDA's OTC Product Review Division Gets Permanent Director

FDA's OTC Product Review Division Gets Permanent Director

Posted 19 November 2013 | By Alexander Gaffney, RAC

US drug regulators on Monday announced that Theresa "Terri" Michele, now acting director of the Division of Nonprescription Clinical Evaluation (DNCE) within the Office of Drug Evaluation (ODE) IV, had been appointed to the position of a permanent basis.

ODE IV, a division of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is charged with reviewing imaging products and nonprescription (i.e. over-the-counter) drug products.

Its DNCE, staffed by approximately 20, is charged with evaluating the safety and efficacy of those products submitted through a new drug application (NDA).

A separate ODE IV division, the Division of Nonprescription Regulation Development (DNRD), is responsible for developing the monographs to which most OTC products adhere to as a condition of approval, and for reviewing submissions of citizen petitions and time and extent applications (TEA).

Michele, an FDA employee since 2007, was previously Medical Team Leader in the Division of Pulmonary, Allergy and Rheumatology Products and has also served on the Chronic Fatigue Syndrome Advisory Committee at the Department of Health and Human Services.

In an email to FDA staff on 18 November, FDA's Sandy Kweder, deputy director of CDER's Office of New Drugs (OND), said Michele had already been instrumental in bridging the gap since the loss of their last DNCE director almost a year ago. Michele is known for her "creative, thoughtful approach to inter-agency cooperation and collaboration," she added.

Michele has also been no stranger to some of FDA's more challenging reviews, including the review of Hemispherx' Ampligen (rintatolimod) for chronic fatigue syndrome (CFS). The CFS community has been vocal about obtaining a treatment for their condition, which currently has no therapies approved for use by the FDA. Ampligen would have been the first to be approved for the condition, but FDA reviewers-including Michele-ultimately concluded in that the drug did not have enough data to support approval at the time of submission, leaving some CFS patients angry enough to start a hunger strike.

Tags: ODE

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