John Kamp, Executive Director of the Coalition for Healthcare Communication, said in an MM&M piece that "2016 may bring more warning letters, guidance from FDA."
As it was designed to do, that headline caught my attention.
"There is a virtual revolution at the FDA in drug marketing enforcement," said Kamp. "The revolution is driven mostly by recent First Amendment challenges to drug communication regulation, especially the Supreme Court's IMS Health decision in 2012, the Caronia federal appeals decision in 2014 and the FDA loss in the Amarin case this past summer.
The turning point, though, was an FDA court settlement with Pacira Pharmaceuticals in December, in which the FDA reversed course and reaffirmed broad indications for Pacira's non-opioid pain medication, Exparel, and rescinded a 2014 warning letter issued by the FDA's OPDP."
"In the past, when a company faced a letter it thought was erroneous, it complained to its lawyers and caved to the FDA. Now, following Pacira's example, such companies can ask for a meeting and probably get it. If not, they can seek court review."
"Expect more letters this year," said Kamp.