Califf: Off-Label Guidance One of FDA’s Top Priorities

May 13, 2016

Addressing off-label promotion is one of the agency’s front burner priorities for 2016, FDA Commissioner Robert Califf said.

Current off-label policies were developed during a time when physicians had limited sources for gathering and processing information, Califf said, noting that current policies are dated, and the FDA needs to reevaluate its regulations on drug advertising and promotion in light of current jurisprudence around the 1st Amendment.

The agency plans on working collaboratively with industry to create comprehensive guidelines for off-label products, he told the Medical Device Manufacturing Association meeting.

Panelists lauded the government’s evolving perspective on off-label products, citing the cases of Amarin and Pacira as first amendment victories.

Under the Amarin ruling, the agency is bound by the terms of an August 2015 injunction permitting Amarin to promote cholesterol drug Vascepa off-label using court-approved language to ensure that the information is truthful and not misleading (IDDM, March 11).

Industry experts have said the Amarin case would have broad implications for devicemakers.

Benjamin Wallfisch, associate at Norton, Rose, Fulbright, cautioned devicemakers not to jump the gun when it comes to promoting a product before it is ready. He recommends that companies work with their marketing teams to make sure their product communications don’t straddle a blurry line while the agency clarifies its regulations. — Joya Patel