Health literacy expert Ruth M. Parker, MD, professor of medicine in the Division of General Medicine at the Emory University School of Medicine, has been appointed to the Federal Drug Administration's (FDA) Non-Prescription Drug Advisory Committee. The committee is responsible for providing recommendations on whether current prescription drugs should be sold as over-the-counter drugs without a prescription.
She will serve on the 12-member committee for three years.
Dr. Parker is a general internist at Grady Memorial Hospital. She was asked to serve on the FDA committee because of her expertise in health literacy -- how well people obtain, process, and understand basic health information and services when making decisions about their health.
"It was certainly very gratifying to know the FDA decided that health literacy mattered enough and that it needed to be considered when making important decisions about medicines and products people will be able to purchase without a prescription," says Dr. Parker, who was appointed to the Institute of Medicine's Committee on Health Literacy in 2002 to study problems related to poor health literacy. "This is an important opportunity to help manufacturers understand the importance of health literacy. This is definitely a topic that cannot be ignored."
"This committee considers whether or not the average American is able to take product information that is made available on labels and read it and understand it in order to be able to act on it," explains Dr. Parker. "In other words, is an informed intermediary necessary, or can a person read and understand labels and warnings well enough to make informed and safe choices on their own."
"It's up to the manufacturer to prove to the FDA that the product is safe and ready for that transition," she adds.
The committee is part of the FDA's Center for Drug Evaluation and Research. After hearing testimony from the FDA, drug manufacturer and public testimonies from various individuals, the committee renders its opinion on whether prescription drugs will be available as over-the-counter drugs.
"The committee takes the evidence and tries to make an informed decision," she says. "There are very strong opinions that weigh in from industry and politics. Our job as a committee is to take evidence and try to give an evidence-based judgment on it."
Dr. Parker has focused extensively on healthcare issues of underserved populations and on health literacy. Most notably, she chaired the Expert Panel on Health Literacy, Council of Scientific Affairs, for the American Medical Association (AMA) that authored a frequently cited JAMA white paper on health literacy. She co-authored the National Library of Medicine Complete Bibliographies of Medicine on Health Literacy, and is chair of the Steering Committee for the AMA Foundation Signature Program: Partnership in Health ¬ Improving the Patient-Physician Relationship Through Health Literacy.
Dr. Parker is also chair of the programs committee for the American College of Physicians Foundation, which has several national initiatives devoted to improving health literacy. She has received numerous grants for health literacy research, from organizations including the Robert Wood Johnson Foundation and the Prudential Center for Health Services Research.