Seven large pharmaceutical companies have filed a Citizen Petition
with the US Food and Drug Administration (FDA) asking the agency to
clarify its rules regarding communication about drugs’ off-label uses.
Communications about medicines’ unapproved or “off-label” uses have long
been a problem for drugmakers and have cost some companies hundreds of
millions of dollars. Questions about unsolicited requests for
information, the use of third-party clinical guidelines and what
companies can say to payers about off-label uses for their products
remain unresolved. “Unfortunately, the current state of regulatory
guidance is not clear or comprehensive, or in some cases, even binding,”
wrote lawyers representing Allergan, Eli Lilly, Johnson & Johnson,
Novartis, Novo Nordisk, Pfizer and Sanofi. “That lack of clarity places
manufacturers at risk of criminal and civil sanctions if they cannot
correctly guess where the government would draw a line.”
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