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ADA joins FDA stakeholder meeting

December 07, 2016

By Jennifer Garvin

Silver Spring, Md. — The ADA was one of several health organizations invited to a Dec. 6 stakeholder meeting with the Food and Drug Administration.

The meeting, led by FDA Commissioner Robert Califf, M.D., was designed to help FDA hear firsthand about key issues facing some of the nation's top health care organizations. Among the topics that dominated the discussion: opioids and how to combat the national prescription drug epidemic.


Dr. Crowley
Dr. Joe Crowley, ADA president-elect, asked how the ADA could help the agency make prescriber education and training programs more relevant to dentists.

"The problem is that most of the education and training programs have been tailored to physicians," Dr. Crowley told the participants. "It would be helpful if the agency addressed the nuances of managing pain in dentistry as opposed to medicine."

Dr. Califf was joined by several senior FDA staff representing the agency's medical, science and policy areas. In addition to the ADA, stakeholders included the American Medical Association, American Nurses Association and American Pharmacists Association.

Dr. Crowley also used his discussion time to ask what the ADA can do to help strengthen the FDA's authority to regulate tobacco products.

"We fought hard to get the Tobacco Control Act passed," said Dr. Crowley, who also noted the ADA's success with keeping oral health warning labels on smokeless tobacco products. "Now we're trying to keep kids from getting hooked on e-cigarettes, snus, other 'next generation' tobacco products."

FDA officials were unable to answer when the agency would be finalizing its monograph for over-the-counter oral health care drug products. The monograph would outline the safety and effectiveness standards oral health drugs would have to meet to be authorized for over-the-counter use, such as acceptable ingredients, doses, formulations and labeling.