September 23, 2013

Ex-FDA official outlines regulatory challenges at Research Day

Dr. Larry Kessler, a former top official at the U.S. Food and Drug Administration, discussed the formidable challenges in getting new dental technology through the regulatory process in a keynote address at the School of Dentistry’s annual Research Day on Sept. 20.

Dr. Larry Kessler

Dr. Larry Kessler

Dr. Kessler, who was Director of the Office of Surveillance and Biometrics at the FDA’s Center for Devices and Radiological Health until 2008, is Professor and Chair of the Department of Health Services in the UW School of Public Health. He described the FDA’s sprawling, cumbersome regulatory mechanisms and processes, which in one instance took seven years to begin fixing hazards in hospital bed rails after they were identified.

Among the improvements he called for were more consistent and sometimes higher standards for the marketplace, especially for medical devices, along with improved guidance documents and performance standards. He also called for improvements in assessing products and devices after they reach the market – what he termed “post-market programs with teeth.”

In discussing dental technology, Dr. Kessler cited temporomandibular joint  (TMJ) implants, which came out in 1976 and were reclassified in 1993. However, it took another five years for the FDA to request pre-market approvals after the reclassification.

Underscoring the need for a stringent approval process is the difficulty in recalling products when a problem crops up. “Getting products off the market is one of the hardest things to do,” Dr. Kessler said. “You almost have to show bodies in the street.”

School of Dentistry faculty also presented talks during the day’s morning session at the Health Sciences Center. They were:

  • Dr. Johan Aps, Clinical Associate Professor of Pediatric Dentistry, who presented “Diagnostics in Dentistry: The Radiologist’s Toolbox.”
  • Dr. Richard Presland, Associate Professor of Oral Health Sciences and Director of the Oral Biology Graduate Program, who presented “Using Saliva and Proteomics as Tools to Understand Chronic Graft-Vs.-Host Diseases.”
  • Dr. Mark Drangsholt, Professor and Chair of the Department of Oral Medicine, who presented “Neurosensory Testing for Diagnosis of Orofacial Pain.”
Second-year student Kevin Huang, who won the ADA Clinician Scholar Award, outlines his project.

Second-year student Kevin Huang, who won the ADA Clinician Scholar Award, outlines his project.

In another one of the day’s highlights, 28 students gave research poster presentations in the Health Sciences lobby. Kevin Huang (’16) received the 2013 American Dental Association Clinician Scholar Award for his project, titled  “Ni(II) Alters Gingival Innate Immunity Under Bacterial Stimulation.” Huang, whose co-author was Sucheol Gil of Oral Health Sciences, was mentored by Dr. Sun Oh Chung of Oral Health Sciences. As winner of the ADA award, Huang will represent the School of Dentistry in the National Student Research Competition at the 2014 ADA meeting in San Antonio, Texas.

Other student finalists chosen by the Research Advisory Committee were Nicolette Bohn (’16), Rochelle Burke (’17), Sam Finkleman (’16) and Dennis Wang (’17) as finalists to participate in this competition.  Finalists were judged in three categories: quality of science; organization and clarity of presentation; and apparent depth of understanding of the project/area.

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