An article by Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, titled "A Difficult Balance - Pain Management, Drug Safety, and the FDA," appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.
In the article, Woodcock discusses FDA efforts to strike a balance between access to pain medication for those who need it and managing the risks posed by various analgesics. As examples, she cites recent FDA actions on acetaminophen, the low-potency opioid propoxyphene, and high-potency opioids such as Oxycontin.
These actions are part of the FDA's ongoing Safe Use Initiative, aimed at reducing the likelihood of preventable harm from medication use. Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient's condition. Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm.
U.S. Food and Drug Administration