A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at a renewed debate over whether and how the Food and Drug Administration (FDA) should regulate the pharmaceutical industry's communication to physicians about off-label uses of drugs. When a drug is prescribed "off label," that means it is being given to a patient for indications that have not been specifically approved by the FDA.
According to information issued by the Agency for Healthcare Research and Quality (AHRQ) in 2015, an estimated one in five prescriptions written are for off-label use. In some cases, such use is the accepted standard of care and recommended in clinical practice guidelines. The recent debate was spurred in part by high-profile recent court cases and shifts in the health care landscape.
At the center of the debate over off-label communication is the question of how the FDA can best safeguard public health while also supporting fully informed decision making by providers and patients. As the brief points out, the official mechanism for a drug manufacturer to expand a drug's use, a New Drug Application, requires new clinical trials and other costly and time-consuming efforts.
Manufacturers frequently argue that additional uses of new drugs could help advance medical knowledge and practice. However, as the brief notes, weakening off-label regulations could further intensify problems such as the lack of high-quality evidence and pose greater risks to patients.
About Health Policy Briefs
Health Policy Briefs are aimed at policymakers, congressional staffers, and others needing short, jargon-free explanations of health policy basics. The briefs, which are reviewed by experts in the field, include competing arguments on policy proposals and the relevant research supporting each perspective.
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