News Feature | February 4, 2014

FDA Expected To Address Off-Label Marketing

Source: Bioprocess Online

By Marcus Johnson

The FDA is expected to address the practice of pharmaceutical companies making off-label claims about their products. Pharmaceutical companies cannot legally make off-label claims and are required to fully disclose any side-effects in any advertisements. While doctors can prescribe drugs for a number of different uses, drug companies can only market drugs for uses approved by the FDA.

Emily Wright, a corporate attorney for Pfizer claimed that the FDA’s enforcement is likely to increase in the near future. “We’ve seen some in the past couple of years and we might be starting to see this even more, and this is some attention being paid by the government and OPDP (The Office of Prescription Drug Promotion) to statements that are made in press releases and various other forms of media. It’s been pretty significant in shaping the environment and pointing us towards what we might see going forward.”

Wright noted that the FDA issued two warnings to pharmaceutical companies in 2012 over news releases about their products. Another recent warning was given to Aegerion Pharmaceuticals for claims made about their product by CEO Marc Beer on television. This past November, the US Department of Justice came to a $2.2 billion settlement with Johnson & Johnson over their practice of off-label marketing.