FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn?

On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food & Drug Administration (FDA) had withdrawn its accusations, made in the form of a Warning Letter to Pacira (Warning Letter), that the company had engaged in unlawful off-label promotion of its non-opioid pain drug (EXPAREL®) by promoting the drug for uses other than the two that were specifically studied in the company’s pivotal clinical trials. As part of the groundbreaking resolution, which followed a novel legal challenge developed by the regulatory team at Latham & Watkins working closely with Pacira, FDA rescinded the Warning Letter and publicly renounced the regulatory position on which it was based.